Clinical trials: Phase 1
Healthy Volunteers
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
- Trial name
- NCT05688085
- Testing
- Irbesartan High/Amlodipine FDC, Irbesartan High, Amlodipine
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
Healthy Volunteer
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants
This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants.
- Trial name
- NCT02015715
- Testing
- RO6864018
- Where
- 2 sites in Singapore
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
TB
Study of the Safety and Immunogenicity of Bacille Calmette Guerin (BCG) Vaccine
Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb).
- Trial name
- NCT00654316
- Testing
- BCG
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2).
- Trial name
- NCT03682484
- Testing
- MA-0211
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Influenza, Human
Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody…
- Trial name
- NCT06028347
- Testing
- sa-mRNA vaccine Dose 1, sa-mRNA vaccine Dose 2, sa-mRNA vaccine Dose 3
- Where
- 2 sites in Australia
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Seqirus
Healthy Volunteers
A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers
The purpose of this study is to measure brain exposure of [11C]savolitinib in healthy volunteers. This study will determine brain exposure of [11C]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when…
- Trial name
- NCT06348355
- Testing
- [11C]savolitinib, Savolitinib
- Where
- Sweden
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.
- Trial name
- NCT06326606
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Healthy Volunteers
A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.
- Trial name
- NCT05395104
- Testing
- Midazolam, Cefiderocol
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Volunteer Study
A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers
- Trial name
- NCT06757738
- Testing
- TRX-100
- Where
- Australia
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Traws Pharma, Inc.
Tuberculosis
Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated…
- Trial name
- NCT03017378
- Testing
- TB/FLU-01L
- Where
- Kazakhstan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Research Institute for Biological Safety Problems
Healthy
Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects
Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its metabolites including excretion and mass balance of parent compound and radioactivity; to isolate, identify and quantify major radiolabeled…
- Trial name
- NCT02211885
- Testing
- 14C-BIRB 796 BS
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers. This study includes 2 parts.
- Trial name
- NCT05158335
- Testing
- MBX 2109 (Part A), MBX 2109 (Part B)
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- MBX Biosciences
Healthy
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.
- Trial name
- NCT00919867
- Testing
- SPD503, VYVANSE, SPD503 and VYVANSE
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shire
Hepatic Impairment, Healthy Participants
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
- Trial name
- NCT04193436
- Testing
- PF-06835919 25 mg
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Hepatitis B
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects.
- Trial name
- NCT05310487
- Testing
- 162
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Yangshengtang Co., Ltd
Healthy
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects.
- Trial name
- NCT03981887
- Testing
- Nafithromycin
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy Subjects
A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males
This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers.
- Trial name
- NCT02072993
- Testing
- AZD1979
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities
The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same…
- Trial name
- NCT02127593
- Testing
- Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process), Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
- Where
- Netherlands
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Aspergillos, Mucormye
Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
Background: Fungal infections can cause serious disease in the lungs and other parts of the body. About 3.8 million people die with fungal infections each year.
- Conditions
- Aspergillos, Mucormye, Dimorphic, Other Molds
- Trial name
- NCT07704333
- Testing
- [18F]-Fluorocellobiose ([18F]FCB)
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Respiratory Syncytial Virus (RSV)
Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older
This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older
- Trial name
- NCT07807449
- Testing
- Recombinant RSV Vaccine (CHO Cell), Adjuvant Suspension, Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension
- Where
- China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Yikang Biotech (Suzhou) Co., Ltd.
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