Clinical trials: Phase I
Neoplasms
A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.
- Trial name
- NCT03926013
- Testing
- JNJ-63898081
- Where
- 7 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Obstructive Pulmonary Disease (COPD), COPD
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects
The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male…
- Trial name
- NCT04756960
- Testing
- CHF6001
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Multiple Myeloma
A Study Evaluating Safety, Tolerability and Clinical Activity of FHND6091 in Patients With Multiple Myeloma
This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory…
- Trial name
- NCT05271682
- Testing
- FHND6091
- Where
- 6 sites in China
- Volunteers
- 40 people
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Healthy Volunteer
A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
- Trial name
- NCT02471859
- Testing
- GDC-3280
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Glioblastoma, Glioma
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma.
- Trial name
- NCT01547546
- Testing
- GDC-0084
- Where
- 5 sites in United States, Spain
- Volunteers
- 29 people
- Sponsor
- Genentech, Inc.
Migraine Headache
Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults
A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE) following a single dose administration of INP104 (DHE administered by I123 Precision Olfactory Delivery (POD) Device Nasal Spray) to that…
- Trial name
- NCT03401346
- Testing
- INP104, Dihydroergotamine Mesylate (DHE), Migranal Nasal Spray
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Impel Pharmaceuticals
Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL)
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and…
- Trial name
- NCT00614042
- Testing
- TRU-016 (anti-CD37 protein therapeutic)
- Where
- 7 sites in United States
- Volunteers
- 96 people
- Sponsor
- Aptevo Therapeutics
Type 1 Diabetes Mellitus
Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes
The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled insulin administration with 3 different inhalation regimens and with subcutaneous insulin administration.
- Trial name
- Samba-01 (NCT02713841)
- Testing
- inhaled human insulin (INH), sc insulin lispro (LIS)
- Volunteers
- 12 people
- Sponsor
- Dance Biopharm Inc.
Premature Ejaculation
A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation
A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline…
- Trial name
- NCT01184105
- Testing
- Intervention A, Intervention B
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Plethora Solutions Ltd
Non-alcoholic Steatohepatitis
Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a…
- Trial name
- NCT06716905
- Testing
- ACT500 tablets
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Advanced Solid Tumor, Hematological Malignancy
An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies
This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.
- Trial name
- NCT06225856
- Testing
- YY201
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Shanghai Yuyao Biotech Co., Ltd.
Acne Vulgaris
A Study to Evaluate the Potential of Tazarotene Foam to Cause a Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers
The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.
- Trial name
- NCT01115322
- Testing
- Tazarotene Foam without irradiation, Tazarotene Foam with UVA and UVB irradiation, Tazarotene Foam with UVA, UVB, and visible light
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Stiefel, a GSK Company
Solid Tumors
Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors
The purpose of this study is to determine the tolerability of ME-344, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
- Trial name
- ME-344-001 (NCT01544322)
- Testing
- ME-344
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- MEI Pharma, Inc.
Prevention of Infection With HIV-1
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers.
- Trial name
- TMB-108 (NCT01292174)
- Where
- 6 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- TaiMed Biologics Inc.
Myeloproliferative Neoplasms
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
- Trial name
- NCT07008118
- Testing
- INCA035784
- Where
- 26 sites in United States, Australia and 3 more
- Volunteers
- 120 people
- Sponsor
- Incyte Corporation
Advanced and/or Metastatic Solid Tumours
Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and tolerability to determine MTD and preliminary…
- Trial name
- POTENTIA (NCT04839991)
- Testing
- CB307
- Where
- 20 sites in United States, Netherlands and 2 more
- Volunteers
- 70 people
- Sponsor
- Crescendo Biologics Ltd.
Peritoneal Neoplasms
Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers
The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally…
- Trial name
- NCT00666991
- Testing
- nanoparticulate paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- CritiTech, Inc.
Healthy
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278…
- Trial name
- NCT01656018
- Testing
- TMC278, Long acting (LA)
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer Metastatic
A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer
This study is a multicenter phase I/II study of the treatment of patients with metastatic prostate cancer. The objective of Phase I part is to study the safety and tolerability of LAE001 monotherapy in patients with metastatic…
- Trial name
- NCT03843918
- Testing
- LAE001
- Where
- 2 sites in China
- Volunteers
- 33 people
- Sponsor
- Laekna Limited
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
- Trial name
- AUR-201 (NCT06072040)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Auregen Biotherapeutics, SA
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