Clinical trials: Phase 1b
Human Metapneumovirus and Human Parainfluenza Infection
Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose…
- Trial name
- NCT04144348
- Testing
- mRNA-1653
- Where
- 19 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Functional Dyspepsia
Study of Aolanti Weikang Tablets in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers
- Trial name
- NCT03358485
- Testing
- Aolanti Weikang tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Moderate-to-severe Atopic Dermatitis
Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with…
- Trial name
- NCT06934252
- Testing
- TRB-061
- Where
- 19 sites in Australia, New Zealand
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- TRex Bio, Inc.
Healthy Volunteers, Diabetic Neuropathies
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic…
- Trial name
- NCT04106050
- Testing
- BIIB095, BIIB074, Lidocaine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Biogen
Hematopoietic Syndrome Due to Acute Radiation Syndrome
Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.
- Trial name
- NCT01742221
- Testing
- HemaMax
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Neumedicines Inc.
Chronic Hepatitis B
A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects
A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects
- Trial name
- NCT05561530
- Testing
- ALG-125755
- Where
- 4 sites in Bulgaria, Moldova and 2 more
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Malaria
Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.
- Trial name
- NCT02458092
- Testing
- Plasmodium falciparum Malaria Protein 010 (FMP010), Rabipur
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability, and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4 chronic kidney disease.
- Trial name
- NCT04072432
- Testing
- RBT-3
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Pulmonary Fibroses, Idiopathic
Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis
The purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF).
- Trial name
- NCT06589219
- Testing
- CMR316
- Where
- Germany
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Calibr, a division of Scripps Research
Staphylococcal Infections, Yeast Infections
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp.
- Conditions
- Staphylococcal Infections, Yeast Infections, Candidiasis
- Trial name
- NCT01447407
- Testing
- NDV-3 vaccine with alum IM, NDV-3 vaccine without alum IM, NDV-3 vaccine without alum ID
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- NovaDigm Therapeutics, Inc.
Intraocular Pressure
A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.
- Trial name
- NCT01284309
- Testing
- Mirabegron
- Where
- 2 sites in United States
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Psoriasis, Atopic Dermatitis
A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Evelo will investigate the safety and tolerability of EDP1066 and its potential to be a medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and atopic dermatitis.
- Trial name
- NCT03542994
- Testing
- EDP1066
- Where
- 7 sites in United Kingdom
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Evelo Biosciences, Inc.
HIV Infections
Antigenic Competition in HIV Preventive Vaccines
HIV vaccines are designed to create an immune response to certain components of the HIV virus called peptides. Previous research indicates that one peptide, called Gag, may be particularly important for stimulating an immune…
- Trial name
- NCT01159990
- Testing
- rAd5 Gag-Pol Env A/B/C, rAd5 Gag-Pol
- Where
- 7 sites in United States, Brazil and 2 more
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Ulcerative Colitis
A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)
This study is only for the first in human phase 1a study designed to investigate the safety and tolerability of LIV001 in healthy participants.
- Trial name
- NCT05975047
- Testing
- LIV001
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Liveome Inc.
Ricin Poisoning
ID Recombinant Ricin Toxin A-Chain 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 or 20 μg…
- Trial name
- NCT02386150
- Testing
- RVEc
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Healthy Participants, Healthy Subjects
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different…
- Conditions
- Healthy Participants, Healthy Subjects, Healthy Volunteers, Autoimmune Diseases
- Trial name
- NCT06342713
- Testing
- BGB-45035
- Where
- 13 sites in Australia, China and 1 more
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BeiGene
Healthy Volunteers
Effects of CSL324 in the Lung After Segmental Challenge
This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in…
- Trial name
- NCT05653713
- Testing
- CSL324
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Psoriasis
A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.
- Trial name
- NCT03445013
- Testing
- SB414 6%, Vehicle
- Where
- 4 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Novan, Inc.
Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome
Multi-antigen Specific CD8+ T Cells With Decitabine and Lymphodepleting Chemotherapy for the Treatment of Patients With Relapsed or Refractory AML or MDS Following an Allogeneic Hematopoietic Cell Transplantation From a Matched Donor
This phase I trial tests the safety, side effects and best dose of NEXI-001 when given with decitabine and lymphodepleting chemotherapy in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that…
- Conditions
- Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome
- Trial name
- NCT06572631
- Testing
- Allogeneic CD8+ Leukemia-associated Antigens Specific T Cells NEXI-001, Biospecimen Collection, Bone Marrow Aspiration
- Volunteers
- healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Seneorineural Deafness, Sudden Sensorineural Hearing Loss
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage…
- Trial name
- NCT06249919
- Testing
- NS101
- Where
- 16 sites in South Korea
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Neuracle Science Co., LTD.