Clinical trials: Phase 1b
Healthy Volunteers
TAK-071 Scopolamine-Induced Cognitive Impairment Study
The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning Test (GMLT) (total number of errors).
- Trial name
- NCT02918266
- Testing
- Scopolamine, TAK-071, Donepezil
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Takeda
Oligozoospermia
A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects
This is a Phase 1b, randomized, double-blind, placebo-controlled, single and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902
- Trial name
- NCT06948799
- Testing
- STSP-0902 injection
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Elevated Blood Pressure, Hypertension
HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood…
- Trial name
- NCT07644364
- Testing
- HJB647
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
COVID-19
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
- Trial name
- NCT04591717
- Testing
- hAd5-S-Fusion+N-ETSD vaccine
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
Norovirus
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988.
- Trial name
- NCT07198139
- Testing
- CDI-988, Snow Mountain Virus
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cocrystal Pharma, Inc.
Hypoparathyroidism, Osteoporosis
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with modified oral formulations (EBP11, EBP11-F1, EBP11-F2, EBP11-F4, EBP11-F5 and EBP22) versus three dose levels of…
- Conditions
- Hypoparathyroidism, Osteoporosis, Fractures, Bone, Other Disease
- Trial name
- NCT05965167
- Testing
- EBP05, Forteo 0.02 mg, EBP11
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Entera Bio Ltd.
Long QT Syndrome
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects.
- Trial name
- NCT05906732
- Testing
- LQT-1213, Dofetilide 250 μg Cap
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
NASH - Nonalcoholic Steatohepatitis, Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X…
- Trial name
- NCT03976687
- Testing
- EYP001a
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
Alzheimer's Disease, Healthy Elderly
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among…
- Trial name
- NCT06546995
- Testing
- NMRA-323511
- Where
- 26 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Neumora Therapeutics, Inc.
Healthy
First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b
Tuberculosis (TB) is an infection caused by bacteria passed from one person to another through the air when an infected person for instance coughs, speaks, or sneezes.
- Trial name
- nTB-01 (NCT06050356)
- Testing
- H107e, CAF®10b, H107e/CAF®10b - low adjuvant dose
- Where
- South Africa
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Pulmonary Arterial Hypertension
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial…
- Trial name
- AIR001-CS02 (NCT00814645)
- Testing
- Sodium Nitrite Inhalation Solution
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aires Pharmaceuticals, Inc.
Ebola Virus Disease, Marburg Virus Disease
Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Primary Objective: To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.
- Trial name
- NCT04723602
- Testing
- cAd3-Marburg, cAd3-EBO-S
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Albert B. Sabin Vaccine Institute
HIV Infection
Safety of and Immune Response to Vaccination With 2 Experimental HIV Vaccines in Healthy Adults
The HIV Vaccine Trials Network (HVTN) is doing a study to test 2 experimental HIV vaccines in combination with 2 licensed vaccines for tetanus and hepatitis B. HIV is the virus that causes AIDS.
- Trial name
- HVTN 097 (NCT02109354)
- Testing
- ALVAC-HIV, AIDSVAX B/E, Hepatitis B vaccine
- Where
- 3 sites in South Africa
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
Renal Cell Carcinoma
Evaluation of the Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients With Advanced Renal Cell Carcinoma
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in patients with advanced renal cell carcinoma.
- Trial name
- NCT05798455
- Testing
- Sodium Pentaborate
- Where
- Iran
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tabriz University of Medical Sciences
Norovirus Infections
Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and…
- Trial name
- VXA-NVV-105 (NCT04875676)
- Testing
- VXA-G1.1-NN
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vaxart
Healthy Volunteers
Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via…
- Trial name
- NCT01765426
- Testing
- TDV
- Where
- 2 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Takeda
Malaria
Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP
A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium…
- Trial name
- NCT03542149
- Testing
- 480 mg Piperaquine phosphate, 640 mg Piperaquine phosphate, 200 mg OZ 439
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Post Herpetic Neuralgia, Pain
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy…
- Conditions
- Post Herpetic Neuralgia, Pain, Osteoarthritis, Neuropathic Pain
- Trial name
- NCT06218784
- Testing
- iN1011-N17 HCl Suspension (Part 1), iN1011-N17 HCl Capsule (Part 1), iN1011-N17 HCl Capsule (Part 2)
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- iN Therapeutics Co., Ltd.
Healthy
Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL ER).
- Trial name
- INX-189-005 (NCT01471704)
- Testing
- INX-08189 50 mg, 240 mg verapamil HCL ER, 50 mg dose of INX-08189 and 240 mg verapamil HCL ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb