Clinical trials: Phase 1b
Malaria
MMV533 Plasmodium Falciparum Volunteer Infection Study
A Phase 1b study to assess the safety, tolerability and antimalarial activity of MMV533 against Plasmodium falciparum 3D7 blood stage infection in healthy volunteers
- Trial name
- NCT05205941
- Testing
- MMV688533
- Where
- Australia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Osteoarthritis, Knee
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.
- Trial name
- NCT03472677
- Testing
- Ice Pack and Cooling Device, CNTX-4975-05 (trans-capsaicin), Capsaicin
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Centrexion Therapeutics
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Healthy Subjects, Adult Subjects With Allergic Diseases
A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases
This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have…
- Trial name
- NCT05564221
- Testing
- YH35324, Omalizumab
- Where
- 9 sites in South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy Volunteers
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B).
- Trial name
- NCT05043766
- Testing
- PF614, Naltrexone Hydrochloride, OxyContin
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ensysce Biosciences
Recurrent Genital Herpes Simplex Type 2
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 in Part B in…
- Trial name
- NCT06698575
- Testing
- ABI-1179
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
HIV Infections
Examining the Role of Genetics in Determining the Immune Response to an HIV Vaccine in HIV-Uninfected Adult Twins
The purpose of this study is to examine the role of genetics in determining the immune response to an HIV vaccine in pairs of HIV-uninfected twins.
- Trial name
- NCT01054872
- Testing
- HIV-1 DNA plasmid vaccine, HIV-1 recombinant Ad5 vaccine
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Obesity
ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).
- Trial name
- NCT01507077
- Testing
- ZGN-440, ZGN-440 sterile diluent
- Where
- Australia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Zafgen, Inc.
Healthy Volunteers
LYT-300 in Healthy Volunteers
Part 1 is a single ascending dose (SAD) trial in healthy volunteers (HV) to assess the safety, tolerability, and pharmacokinetic (PK) profile of orally administered LYT-300.
- Trial name
- NCT05129865
- Testing
- LYT-300
- Where
- Australia
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- PureTech
HIV Infections
Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected Adults
The purpose of this study is to intensively characterize the immune response, particularly the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in HIV-uninfected adults.
- Trial name
- NCT00486408
- Testing
- MRKAd5 HIV-1 gag/pol/nef
- Where
- 4 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 5
BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants
This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and…
- Conditions
- Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 5, EBV-Related Lymphoproliferative Disorder, EBV-Related Malignant Neoplasm
- Trial name
- NCT06741072
- Testing
- Biospecimen Collection, Dulbecco''s Phosphate-Buffered Saline, Peptide Vaccine
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Ohio State University Comprehensive Cancer Center
Ricin Poisoning
IM Recombinant Ricin Toxin Vaccine (RVEc) - 3-Dose Primary Series With Boost
This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM.
- Trial name
- NCT02385825
- Testing
- RVEc
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
HIV Infections
Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals
The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.
- Trial name
- NCT00955006
- Testing
- VRC-HIVDNA-016-00-VP, VRCHIVADV014-00-VP
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy…
- Trial name
- ABCI (NCT05802264)
- Testing
- ABCI
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Cystetic Medicines, Inc.
Alcohol Use Disorder
Phase 1b Study of DCR-AUD in Healthy Volunteers
The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers.
- Trial name
- NCT05845398
- Testing
- DCR-AUD
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Pharmacokinetics, Safety Issues
PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
- Conditions
- Pharmacokinetics, Safety Issues, Bleeding
- Trial name
- NCT05041699
- Testing
- IPM Ring-105, IPM Ring-106
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
- Trial name
- NCT03642847
- Testing
- Prevnar 13, multivalent pneumococcal conjugate formulation 1, multivalent pneumococcal conjugate formulation 2
- Where
- 4 sites in United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Pfizer
Alzheimer's Disease, Healthy Participants
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease
This is a Phase 1/1b, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL921 in healthy…
- Trial name
- NCT07758595
- Testing
- DNL921
- Where
- United Kingdom
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Denali Therapeutics Inc.
Netherton Syndrome
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
This is a first-in-human, Phase 1/1b, 4-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult…
- Trial name
- NCT06539507
- Testing
- BCX17725
- Where
- 12 sites in United States, Australia and 3 more
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Healthy Volunteers
A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol
This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male…
- Trial name
- NCT03203499
- Testing
- ANS-6637 Oral Tablet
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amygdala Neurosciences, Inc.