Clinical trials: Phase 1b
Chronic Hepatitis B
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers.
- Trial name
- NCT02908191
- Testing
- ABI-H0731, Entecavir, Tenofovir disoproxil fumarate
- Where
- 2 sites in New Zealand
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Diabetes Mellitus, Type 2
A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM
- Trial name
- NCT03646721
- Testing
- DA-1241, Sitagliptin
- Where
- 4 sites in United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Myeloproliferative Neoplasms
Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation
The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while…
- Trial name
- MPN (NCT06291987)
- Testing
- Ivosidenib, Ruxolitinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Pneumococcal Infectious Disease
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years.
- Trial name
- NCT06183216
- Testing
- Sinovac PCV13, PREVNAR 13
- Where
- China
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Sinovac Research and Development Co., Ltd.
H3N2 Influenza
Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine
This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of 200 children, ages 6 months to 17 years.
- Trial name
- NCT04960397
- Testing
- Sing2016 M2SR H3N2
- Where
- 4 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
First-in-human Study of VE303 in Healthy Adult Volunteers
This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics…
- Trial name
- NCT04236778
- Testing
- VE303, Oral Vancomycin
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Vedanta Biosciences, Inc.
Leprosy
Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
This is a phase 1b/2a, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE investigational vaccine compared to placebo.
- Trial name
- NCT03947437
- Testing
- LEP-F1 + GLA-SE
- Where
- Brazil
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Crohn's Disease
Positron Emission Tomography (PET) Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
The purpose of this study is to measure the changes in small bowel uptake of radioligand [11^C]AZ14132516 after intravenous (IV) administration of single and repeat doses of AZD7798 in healthy participants and participants with…
- Trial name
- NCT06053424
- Testing
- AZD7798, [11C]AZ14132516
- Where
- Sweden
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Atopic Dermatitis (AD), Eczema
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)…
- Trial name
- NCT07453602
- Testing
- ARQ-234
- Where
- 7 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Arcutis Biotherapeutics, Inc.
Healthy
A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803
The purpose of this study is to assess the pharmacokinetics, excretion, mass balance and metabolism of PF-07265803 (formerly known as ARRY-371797) in approximately 6 healthy adult male participants.
- Trial name
- NCT05286281
- Testing
- PF-07265803
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Obesity, Morbid Obesity
Effects of RM-493 on Energy Expenditure in Obese Individuals
Background: RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It has helped to reduce body weight and improve insulin sensitivity in lab tests.
- Trial name
- NCT01867437
- Testing
- RM-493
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Covid19
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and…
- Trial name
- NCT04732468
- Testing
- hAd5-S-Fusion+N-ETSD (Suspension for injection), hAd5-SFusion+ N-ETSD (Oral capsule)
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
Healthy Participants, Schizophrenia Diagnosis
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.
- Trial name
- NCT07344948
- Testing
- NTX-253
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Neurosterix
Optical Coherence Tomography of Retina, Alzheimer Disease
Comparative Study of High Performance Low-Cost Optical Coherence Tomography (Stage 1B, 2 and 3)
The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device.
- Trial name
- NCT07425106
- Testing
- retinal imaging with low-cost OCT-a/LCI device
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Duke University
Recurrent or Metastatic Colorectal Cancer
Combination of Nelmastobart and Capecitabine Therapy in Metastatic Colorectal Cancer
This is an open-label clinical trial aimed at evaluating the safety and efficacy of the combination treatment of nelmastobart with capecitabine in patients diagnosed with metastatic or recurrent colorectal cancer.
- Trial name
- NCT05990543
- Testing
- Nelmastobart and Capecitabine
- Where
- South Korea
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Korea University Anam Hospital
Nipah Virus Infection
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects.
- Trial name
- NCT06221813
- Testing
- PHV02, Lactated Ringer's
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Public Health Vaccines LLC
Healthy Volunteers, Anti-Bacterial Agents
A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin® SAL200 following single and multiple ascending doses in healthy male volunteers after continuous intravenous infusion over 60 minutes.
- Conditions
- Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
- Trial name
- NCT03446053
- Testing
- N-Rephasin® SAL200
- Where
- South Korea
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Malaria,Falciparum
A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants
This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.
- Trial name
- NCT03580824
- Testing
- R21 in Matrix- M adjuvant vaccine
- Where
- Kenya
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Cytomegaloviral Infection, Hematopoietic and Lymphoid System Neoplasm
A Cytomegalovirus-Directed Vaccine (CMV-alphaDC1) for Preventing Cytomegalovirus Infection or Reactivation in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
This phase Ib trial evaluates the safety and most effective dose of a cytomegalovirus (CMV) pp65 peptide-loaded alpha-type-1 polarized dendritic cell (CMV-alphaDC1) vaccination in patients who are undergoing an allogeneic…
- Trial name
- NCT05589844
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, CMV pp65 Peptide-loaded Alpha-type-1 Polarized Dendritic Cell Vaccine
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Roswell Park Cancer Institute