1 e, we extend these preclinical findings by a
first-in-human (
11)C-metformin PET dosimetry, biodistrib
2 First-in-human (
64)Cu-FBP8 fibrin-targeted positron emis
3 First-in-human (
68)Ga-PSMA I&T PET imaging allowed high-
4 We assessed pre-clinical toxicology and
first-in-human administration of C34-PEG4-Chol.
5 First, in humans and animals, activation of the immune s
6 nclude children younger than age 18 years in
first-in-human and other adult cancer clinical trials.
7 Tisotumab vedotin is a
first-in-human antibody-drug conjugate directed against
8 Purpose To demonstrate preclinical and
first-in-human application of an antibody composed of th
9 of CCR5 using zinc finger nucleases was the
first-in-human application of genome editing and remains
10 Here, we report on a
first-in-human application of responsive deep brain stim
11 ing agents while highlighting the successful
first-in-human application of this technique.
12 Furthermore, a
first-in-humans application was done on 2 patients with
13 For a
first-in-humans application, 173 MBq of [(68)Ga]Ga-AMTG
14 ition of [(11)C]-(R)-3 in primates including
first-in-human assessment.
15 The probability of a
first-in-human at 10 years was 9.8%.
16 In this
first-in-human case study, the combination successfully
17 First-in-Humans case series.
18 Here, we report the
first-in-human characterization of 2 new PDE10A radiolig
19 the early safety and efficacy data from the
first in human clinical cases.
20 l products are currently being developed for
first in human clinical trials in select disorders.
21 CCW702 is being evaluated in a
first in-human clinical trial for men with mCRPC who had
22 To the best of our knowledge, this is the
first in-human clinical trial to assess the safety, tole
23 The multicenter, nonrandomized,
first-in-human clinical CAPTURE (Carotid Artery Implant
24 We report the
first-in-human clinical experience with a novel preforme
25 In addition, we present the
first-in-human clinical experience with MEIS.
26 isease (CUPID 1) study was a phase 1/phase 2
first-in-human clinical gene therapy trial using an aden
27 First-in-human clinical studies of recombinant human IL-
28 ate preclinical evidence prior to initiating
first-in-human clinical studies.
29 In a
first-in-human clinical study ILIT with MAT-Fel d 1 was
30 on was found to be safe and feasible in this
first-in-human clinical study.
31 ally re-induce HbF by DNMT1 inhibition, this
first-in-human clinical trial (NCT01685515) combined 2 s
32 ped, validated, and employed in support of a
first-in-human clinical trial (NCT02991911).
33 llular Immunotherapy for Septic Shock is the
first-in-human clinical trial evaluating allogeneic mese
34 However, the
first-in-human clinical trial of anti-TRBC1 CAR T cells
35 cell manufacturing process, employed in our
first-in-human clinical trial of Cas9-engineered T cells
36 BRAF(V600)-mutated metastatic melanoma in a
first-in-human clinical trial of dabrafenib, trametinib
37 patients with B-cell lymphoma on a phase I,
first-in-human clinical trial of T cells expressing the
38 In conjunction with the phase 1
first-in-human clinical trial of venetoclax in patients
39 Purpose We performed a
first-in-human clinical trial on ultrasound molecular im
40 In a phase 1
first-in-human clinical trial, the menin inhibitor revum
41 escribe its safety and activity in a phase 1
first-in-human clinical trial.
42 silica particle was recently approved for a
first-in-human clinical trial.
43 Consistent with these observations,
first-in-human clinical trials with our ACC inhibitor PF
44 ecies to establish safe starting dosages for
first-in-human clinical trials.
45 (68)Ga-NOTA-2Rs15d is ready for
first-in-human clinical trials.
46 During a
first-in-humans clinical trial investigating electron pa
47 In this
first-in-humans clinical trial of a purified recombinant
48 We conducted the
first-in-humans clinical trial of chimeric antigen recep
49 , and thus for marrow homing, we conducted a
first-in-humans clinical trial to correct this deficienc
50 In a "
first-in-human"
clinical trial, we evaluated the safety
51 Finally, in an open-label
first-in-human cohort of 6 peanut-allergic adults, admin
52 These
first-in-human data introduce a novel macrophage-specifi
53 e conjugate currently tested in a phase 1/2a
first-in-human dosage escalation trial for patients with
54 In this phase 1,
first-in-human dose-escalation and dose-expansion study,
55 CAPRISA 012B, a
first-in-human dose-escalation phase 1 trial evaluated t
56 safety and efficacy results of an open-label
first-in-human dose-escalation phase 1/2 gene therapy cl
57 This
first-in-human dose-escalation study assessed the maximu
58 This
first-in-human dose-escalation trial in 25 previously tr
59 onuclide conjugate currently in a phase 1/2a
first-in-humans dose escalation trial for patients with
60 esent the preliminary results of the phase 1
first-in-humans dose-escalation trial evaluating (212)Pb
61 This
first-in-human,
dose-escalation and expansion study eval
62 This phase 1,
first-in-human,
double-blind, parallel, randomised, plac
63 In this
first-in-human,
double-blind, randomized placebo-control
64 Finally,
first-in-human dynamic (18)F-pretomanid PET in six healt
65 Here, we perform
first-in-human dynamic (18)F-pretomanid positron emissio
66 study provided the scientific basis for the
first-in-human endocardial PFA studies.
67 This is the
first-in-human evaluation of a novel aptamer antagonist
68 Development Program (IPCAVD) 001 trial, the
first-in-human evaluation of a prototype Ad26 vector-bas
69 adiation dosimetry for (68)Ga-NOTA-UBI and a
first-in-human evaluation to diagnose infectious process
70 The radiotracer is currently undergoing
first-in-human evaluation.
71 Here, we report the
first in-human experience with a cceAAV vector.
72 Here, we summarize the
first-in-human experience in 3 heavily pretreated patien
73 These observations represent a
first-in-human experience of an RNA aptamer and its comp
74 Here we present the
first-in-human experience of this chemical class, as wel
75 This study presents, to our knowledge, the
first-in-human experience with (18)F-FEOBV, including ra
76 ical potential of (64)Cu-DOTATATE in a small
first-in-human feasibility study.
77 tion-approved trial, "A Phase 1, Open-Label,
First-in-Human,
Feasibility and Safety Study of Human Sp
78 covery of biomarkers of drug activity before
first in human (
FIH) studies.
79 f the design, implementation, and outcome of
first-in-human (
FIH) trials of monoclonal antibodies (mA
80 In addition, the
first-in-humans (
FIH) dose of 485 mg, determined from th
81 First, in humans,
following PAg binding to the intracell
82 The authors describe a
first-in-human,
fully percutaneous superior cavopulmonar
83 A
first-in-human healthy volunteer study of poseltinib est
84 First, in human heart transplant recipients the total le
85 In anticipation of the "
first-in-human"
heart xenotransplantation trial, we prop
86 This
first-in-human HF efficacy/safety study demonstrates an
87 We therefore undertook a
first-in-human HF proof of concept/safety study, evaluat
88 onal new drug approval was obtained, and the
first-in-humans images with dosimetry using the agent we
89 First-in-human imaging demonstrated multifocal osseous a
90 First-in-human imaging with [(61)Cu]Cu-NODAGA-PSMA-I&T w
91 ogressed through phase I clinical trial as a
first-in-human inhibitor of RNA-POL I.
92 shed both in vitro and in vivo, warranting a
first-in-human investigation in psoriasis.
93 In a single-arm,
first-in-human,
investigator-initiated Food and Drug Adm
94 First, in human Jurkat cells, we characterized the effec
95 the myocardium of this radiotracer, and the
first-in-human measurements of MBF performed in 7 health
96 Here we report interim data from a
first-in-human,
multicenter, open-label, 3 + 3 dose-esca
97 This phase I,
first-in-human,
non-randomized, open-label study evaluat
98 CALM-FIM_EUR was a prospective,
first-in-human,
open-label study done at six European ce
99 Here we report interim results from a
first-in-human,
open-label, nonrandomized, phase 1/2 tri
100 We did an international,
first-in-human,
open-label, phase 1 clinical trial with
101 In this "
first in human oral cavity" study, topical ST266 was saf
102 First, in human peripheral blood T cells (PBT), expressi
103 Here, we describe a
first-in-human PET study on patients with HER2-positive
104 nce characteristics of this radioligand in a
first-in-humans PET study.
105 ic profile, PF-06282999 has been advanced to
first-in-human pharmacokinetic and safety studies.
106 Here we report results of a
first in human phase 1 trial of XmAb5574 in patients wit
107 by us and others(16,21,22), we initiated the
first in-human phase 1 trial of GITR agonism with the an
108 We are at present conducting the
first in-human phase I clinical trial involving the syst
109 As a part of the
first in-human phase I trial investigating deep brain st
110 As a part of the
first in-human phase I trial investigating the effects o
111 A
first-in-human phase 1 clinical study was performed on 1
112 We report a
first-in-human phase 1 clinical trial to test the safety
113 models and is currently being evaluated in a
first-in-human phase 1 clinical trial.
114 e we report updated interim results from the
first-in-human phase 1 evaluation of autologous NKTs co-
115 In our
first-in-human phase 1 study (NCT0308190), second-genera
116 01 part A is an open-label, dose escalation,
first-in-human phase 1 trial of PGDM1400LS given intrave
117 In a
first-in-human phase 1-2a study (GDFATHER-1/2a trial, NC
118 m analysis results of an ongoing single-arm,
first-in-human phase 1/1b study of concurrent intratheca
119 Following previous results from the
first-in-human phase 1/2 clinical trial, we assessed AAV
120 This
first-in-human phase 1/2 study assessed the maximum tole
121 This
first-in-human phase 1/2 study evaluated enasidenib dose
122 Data were combined from part 2 of a
first-in-human phase 1/2 study of patients who relapsed
123 Here we report the
first-in-human phase 1/2 trial findings evaluating VT398
124 A
first-in-human phase I clinical study aimed to assess th
125 was administered in a cell-dose-escalation,
first-in-human phase I clinical trial ( NCT03970382 ).
126 1 TCR for the treatment of solid tumors in a
first-in-human phase I clinical trial (NCT03240861).
127 nt of AL002c is safe and well tolerated in a
first-in-human phase I clinical trial and engages TREM2
128 apy and in combination with gemcitabine in a
first-in-human phase I clinical trial in patients with a
129 This
first-in-human phase I study assessed safety, tolerabili
130 Here we report the
first-in-human phase I study investigating the maximum t
131 ne or with radiation therapy (PATRIOT) was a
first-in-human phase I study of the oral ATR (ataxia tel
132 Here we report the results of a
first-in-human phase I trial in 41 patients with rGBM wh
133 A
first-in-human phase I trial with the clinical candidate
134 We conducted a
first-in-humans phase I study of CTT1057 in patients wit
135 In a
first-in-human (
phase 1), randomized, double-blinded, pl
136 the rate-limiting steps is the initiation of
first-in-human (
phase I) trials.
137 ics, efficacy and biomarker results from the
first-in-human,
phase 1 dose escalation and dose expansi
138 We conducted a
first-in-human,
phase 1 dose-escalation trial of autolog
139 RE 005.2 was an open-label, dose-escalation,
first-in-human,
phase 1 trial done at the Centre for Cli
140 andomised, placebo-controlled, double-blind,
first-in-human,
phase 1 trial evaluated the safety, tole
141 A
first-in-human,
phase 1, double-blinded, randomized 1-we
142 SCIPIO is a
first-in-human,
phase 1, randomized, open-label trial of
143 za vaccine, mRNA-1010, was investigated in a
first-in-human,
phase 1/2 clinical trial conducted in 3
144 NA-1010, from the first 2 parts of a 3-part,
first-in-human,
phase 1/2 clinical trial in healthy adul
145 Here we report interim analyses of a
first-in-human,
phase 1/2, open-label, dose-optimization
146 A
first-in-human,
phase 1/2a, open-label, clinical study o
147 Conclusion: This
first-in-human,
phase I clinical trial demonstrates the
148 This
first-in-human,
phase I clinical trial demonstrates the
149 The aim of this
first-in-human,
phase I clinical trial was to investigat
150 is safe and reduces AF in mice, prompting a
first-in-human pilot clinical trial.
151 This
first-in-human pilot study shows that molecular imaging
152 port key physiological observations from the
first-in-human porcine kidney xenograft over a 51 day po
153 le describes the preclinical development and
first-in-human proof of concept for DSR.
154 We aimed to report results of the
first-in-human proof-of-concept clinical trial in health
155 This
first-in-human proof-of-concept study evaluated the clin
156 This
first-in-human,
proof-of-concept, double-blind, phase 1,
157 Here, we present a
first-in-human prospective study using the 18-kDa transl
158 s: The initial dose escalation phase of this
first-in-humans prospective study included 6 patients (m
159 EASEE II and PIMIDES I were the
first in-human,
prospective, single-arm trials with an 8
160 Finally, we initiated a
first-in-human protocol of [11C]-TMP in patients infecte
161 ese advances have recently culminated in the
first-in-human PSC clinical trials by Geron, Advanced Ce
162 We present the
first-in-humans radiation dosimetry results and biodistr
163 ween Nov 20, 2017, and Sept 10, 2019, in the
first-in-human,
randomised, placebo-controlled, single-a
164 and repeat PVX108 doses were evaluated in a
first-in-human,
randomized, double-blind, placebo-contro
165 We describe a
first-in-human,
randomized, double-blind, placebo-contro
166 Finally, we present
first-in-human results demonstrating non-invasive imagin
167 The favorable tracer biodistribution and the
first-in-human results will make (68)Ga-NOTA-UBI PET/CT
168 ntraoperative detection and resection during
first-in-human RGS.
169 We report the
first-in-human safety and immunogenicity assessment of a
170 We report the
first-in-human safety and immunogenicity assessment of a
171 We report the
first-in-human safety and immunogenicity evaluation of P
172 This
first-in-human series demonstrated that temperature-cont
173 In this
First-in-Human series, diaphragm pacing with a temporary
174 These data are the
first in humans showing that hormone-regulated vitamin s
175 In this multicentre phase 1b,
first-in-human,
single-blind, placebo-controlled trial,
176 In this
first-in-human,
single-center, multioperator trial, VALU
177 For this
first-in-human,
single-centre, phase 1 trial, patients a
178 e gliomas (HGG) are frequently excluded from
first-in-human solid tumor trials because of perceived p
179 nsive, and early study of novel drugs at the
first-in-human stage and the study of established drugs
180 ty, safety, and efficacy data supporting the
first-in-human STEM-PD phase I/IIa clinical trial along
181 In this
first-in-human strategy, 10 patients with stage IV melan
182 ful testing of selective CD28 antagonists in
First In Human studies, this review delineates how this
183 rapy following myeloablative conditioning in
first-in-human studies (trial registry nos.
184 e therapy trials are underway, and many more
first-in-human studies are anticipated.
185 First-in-human studies are currently testing small molec
186 Finally,
first-in-human studies are ongoing, testing adenovirus-m
187 tional exercise from preclinical research to
first-in-human studies for novel PET radiotracers.
188 ate subtherapeutic exposures of new drugs in
first-in-human studies known as exploratory clinical tri
189 hildren have historically been excluded from
first-in-human studies of promising new cancer drugs and
190 rs, New York, NY) to identify any associated
first-in-human studies published by January 2015.
191 First-in-human studies with clinical-grade (18)F-FTC-146
192 First-in-human studies with PSMA radioligands derived fr
193 For these
first-in-human studies, an activating peptide for the hu
194 eier curves were constructed for the time to
first-in-human studies.
195 utic target for aortic valve intervention in
first-in-human studies.
196 ease translation of new PET radiotracers to
first-in-human studies.
197 A
first in human study to evaluate tolerability and pharma
198 Conclusion This
first in-human study focused on mBC suggests that FMX-en
199 In this
first in-human study of a systemically administered near
200 Nevertheless, the safety profile of this
first in-human study of the humanized mAb to IL-2/IL-15R
201 SWITCH) study, a single-center, prospective,
first in-human study, evaluated 5 patients with severe b
202 involvement was a significant predictor of a
first-in-human study (P = 0.02); devices developed with
203 This
first-in-human study aimed to assess the safety, tolerab
204 Here we present the results of a
first-in-human study assessing the safety and effectiven
205 This
first-in-human study demonstrated safety, dosimetry, bio
206 Conclusion: This
first-in-human study demonstrates that tumor-associated
207 This
first-in-human study evaluated the safety, pharmacokinet
208 This
first-in-human study evaluated the safety, tolerability,
209 This multicenter,
first-in-human study evaluated the safety, tolerability,
210 This phase I,
first-in-human study evaluated the safety, tolerability,
211 This
first-in-human study evaluates the safety, pharmacokinet
212 n these preclinical findings, we conducted a
first-in-human study in healthy subjects and showed that
213 In a
first-in-human study in postmenopausal women, once daily
214 This
first-in-human study in previously treated subjects with
215 ve of FLT3-ITD mutation status in a phase I,
first-in-human study in relapsed or refractory AML.
216 This
first-in-human study investigated the safety, tolerabili
217 We conducted the
first-in-human study of (18)F-fluoroethyl triazole [Tyr(
218 We conducted a
first-in-human study of (18)F-MFBG PET imaging to evalua
219 This
first-in-human study of RTH258 demonstrated noninferiori
220 This
first-in-human study of T-DM1 evaluated safety, pharmaco
221 This was a
first-in-human study of the novel phosphodiesterase-2A (
222 This was a
first-in-human study of the PET radiotracer (11)C-LSN317
223 It was a
first-in-human study of the poly (ADP-ribose) polymerase
224 phase I study, which to our knowledge is the
first-in-human study of this kind, investigates the safe
225 In a previous
first-in-human study of venetoclax, 77% of patients with
226 Conclusion: The results of this
first-in-human study support the safety and favorable ph
227 present work, FR104 has been evaluated in a
first-in-human study to evaluate the safety, pharmacokin
228 we report results from two participants in a
first-in-human study using electrical stimulation of cer
229 This
first-in-human study was conducted between August 2017 a
230 uble-blind, dose-escalating, single- center,
first-in-human study was conducted in 36 healthy adults
231 A
first-in-human study was conducted to assess safety, tol
232 A
first-in-human study was conducted to assess the safety,
233 A phase I
first-in-human study was conducted to characterize the s
234 A
first-in-human study was conducted to evaluate the feasi
235 This
first-in-human study was designed to evaluate the safety
236 Purpose This two-part,
first-in-human study was initiated in patients with adva
237 A
first-in-human study was performed with MP0250, a DARPin
238 The purpose of this
first-in-human study was to assess the kinetic and bindi
239 The purpose of this
first-in-human study was to evaluate the ability of (18)
240 Objectives of this
first-in-human study were to characterize the safety, ph
241 -susceptible pulmonary TB were enrolled in a
first-in-human study(4) using dynamic [(11)C]rifampin (a
242 In a
first-in-human study, 21 BCS patients were scanned in vi
243 In the 10 patients of this
first-in-human study, acute bidirectional electrical PV
244 In this
first-in-human study, Chapuis et al. demonstrate that th
245 In this
first-in-human study, low- intensity collimated ultrasou
246 In this
first-in-human study, up to 10 cycles of AMG 420 were gi
247 In this
first-in-human study, we assessed the safety and activit
248 In this
first-in-human study, we demonstrated that in humans wit
249 In what we believe to be a
first-in-human study, we evaluated the safety and dosime
250 sidering which studies are required before a
first-in-human study, we have: (1) classified devices ac
251 toxicology to seek regulatory approval for a
first-in-human study.
252 in serum of ulcerative colitis patients in a
First-In-Human study.
253 terize the pharmacodynamic responses in this
first-in-human study.
254 quency balloon in a multicenter, single-arm,
first-in-human study.
255 These data led to a 2-part
first-in-human study: Part I evaluated safety and pharma
256 This
first-in-humans study investigated the safety, biodistri
257 This
first-in-humans study investigated the safety, tolerabil
258 Conclusion: This
first-in-humans study of PLG in women with uterine and c
259 This
first-in-humans study supports the clinical use of (64)C
260 The purpose of this
first-in-humans study was to evaluate the ability of (18
261 The aim of this
first-in-humans study was to evaluate the biodistributio
262 We report the
first-in-human successful transcatheter tricuspid valve
263 Our study represents the
first in-human testing of these two novel OPV2 candidate
264 herefore, this radiotracer is suitable for a
first-in-human theranostic application and may help to i
265 This study is the
first in humans to demonstrate that specific endothelium
266 First-in-human,
to our knowledge, [(18)F]CFA PET/CT stud
267 First-in-human transplant of the part of the heart conta
268 he Food and Drug Administration approved the
first in-human transplantation of a genetically engineer
269 Recently, we started the
first-in-human treatment with an alpha-radionuclide-labe
270 sPIF received a FDA Fast Track Approval for
first in human trial in autommuninty (completed).
271 in-17 (anti-IL-17) monoclonal antibody, in a
first in-human trial in rheumatoid arthritis (RA) patien
272 Conclusion: This ongoing
first-in-human trial aims to establish the safety, dosim
273 dose administered to patients with CSU in a
first-in-human trial exhibited durable disease symptom r
274 ffects of NK cells post-HSCT, we conducted a
first-in-human trial of adoptive transfer of donor-deriv
275 We address this limitation through a
first-in-human trial of bispecific anti-CD20, anti-CD19
276 nt definitive preclinical studies enabling a
first-in-human trial of DSG3-CAART for mucosal PV.
277 Thus, in preparation for a
first-in-human trial of mesenchymal stromal cells (MSCs)
278 Here we present the results from a
first-in-human trial of the candidate simian adenovirus
279 from a phase I open-label, dose escalation,
first-in-human trial of the ChulaCov19 vaccine (NCT04566
280 The main aims of this
first-in-human trial were to determine maximum-tolerated
281 In a
first-in-human trial, RNA-LPAs elicited rapid cytokine/c
282 In a 3-center, single-arm,
first-in-human trial, the 7.5F lattice catheter was used
283 In a recent,
first-in-human trial, the study was activated and the fi
284 In this dose-finding,
first-in-human trial, treatment-naive adults aged 18-75
285 In this open-label,
first-in-human trial, we have assessed the safety and th
286 In this
first-in-human trial, we investigated the safety of admi
287 In a
first-in-human trial, we recruited five patients at the
288 anitumab was similar to that observed in the
first-in-human trial.
289 participated in the phase 1b component of a
first-in-human trial.
290 ntibody (ozanezumab) was well tolerated in a
first-in-human trial.
291 rapy for glioblastoma is promising; however,
first-in-human trials did not yield significant success
292 Compound 7 was advanced to
first-in-human trials for the treatment of diabetic neph
293 ities and practical steps that would lead to
first-in-human trials of lung cell therapy.
294 In
first-in-human trials, PFA preferentially affected myoca
295 ovided impetus to advancing the field toward
first-in-human trials.
296 In this Article we report two phase 1,
first-in-human trials.
297 this issue of Blood, Uchida et al report the
first-in-human use of a new nonsubstitutive therapy for
298 lation of newly developed optical tracers to
first-in-human use.
299 This paper provides results from
first-in-humans use of (64)Cu-DOTATATE, an avidly bindin
300 Conclusion: The
first-in-humans use of low-dose (124)I-MIBG PET for moni