Clinical trials: Phase 1b
Cystic Fibrosis
Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis
To determine the relative bioavailability of the capsule (reference) and tablet (test) formulations of FDL169 in healthy adult males and females, and to evaluate the pharmacokinetic (PK) profile FDL169 tablets (test formulation)…
- Trial name
- NCT02767297
- Testing
- FDL169
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Flatley Discovery Lab LLC
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT03893799
- Testing
- RBT-1
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Healthy Subjects, Obesity
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects.
- Conditions
- Healthy Subjects, Obesity, Type 2 Diabetes
- Trial name
- NCT05822544
- Testing
- TLC-6740 Oral Solution, TLC-6740 Tablet, Drug Metabolizing Enzyme
- Where
- 4 sites in New Zealand
- Volunteers
- 564 people, healthy volunteers welcome
- Sponsor
- OrsoBio, Inc
Plague
One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins).
- Trial name
- NCT00246467
- Testing
- Alhydrogel, rF1 and rV protein antigens
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- PharmAthene UK Limited
BRCA1/2 Mutation
INO 5401 Vaccination in BRCA1/2 Mutation Carriers
The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations.
- Trial name
- NCT04367675
- Testing
- INO-5401, INO-9012, Cellectra 2000
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV Infections
Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector
This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.
- Trial name
- NCT00801697
- Testing
- DNA Vaccine, rAd35, rAd5
- Where
- 10 sites in United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumococcal Disease, Invasive, Pneumococcal Disease
Serum Collection Study for Assay Development
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
- Trial name
- NCT07205289
- Testing
- Gamma-PN
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GPN Vaccines
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing…
- Conditions
- Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT07020533
- Testing
- Biospecimen Collection, Electronic Health Record Review, Haploidentical Hematopoietic Cell Transplantation
- Where
- 3 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Healthy
A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules…
- Trial name
- NCT01542632
- Testing
- Takeda's Tetravalent Dengue Vaccine Candidate (TDV), TDV New Formulation
- Where
- 3 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Takeda
Atopic Dermatitis (AD)
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy…
- Trial name
- NCT07235384
- Testing
- ZL-1503
- Where
- 12 sites in Australia, China and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Tuberculosis
MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa
MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x 10^5 CFU).
- Trial name
- A-050 (NCT02933281)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Nonalcoholic Fatty Liver Disease
A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
This is a 3 part, randomized, double blind, placebo controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending subcutaneous (SC) doses of CB4211 in…
- Trial name
- NCT03998514
- Testing
- CB4211 Dose 1, CB4211 Dose 2, CB4211 Dose 3
- Where
- 4 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- CohBar, Inc.
Androgenetic Alopecia (AGA)
A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
This study is designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of OLX72021 in medically healthy men with mild to moderate androgenetic alopecia.
- Trial name
- NCT07327359
- Testing
- OLX72021
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Olix Pharmaceuticals, Inc.
Malaria,Falciparum, Malaria
Pyronaridine in Healthy Adult Participants Infected With Blood Stage Malaria
This is an open-label, adaptive study that will utilise the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile of pyronaridine.
- Conditions
- Malaria,Falciparum, Malaria, Malaria Recrudescence, Parasitemia
- Trial name
- NCT05287893
- Testing
- Pyronaridine, P. falciparum IBSM infection
- Where
- 2 sites in Australia
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy Volunteers
A Study to Learn About the Study Medicine Called PF-07258669 in Older Adults Including Those at Risk of Malnutrition
The purpose of this study is to look at safety, tolerability, and pharmacodynamic effects (i.e. how the study drug affects your body) of PF-07258669 in older participants ((60 years to <90 years) including those at risk of…
- Trial name
- NCT07086664
- Testing
- PF-07258669
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
ShigETEC Vaccine Study in Bangladesh
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5…
- Trial name
- NCT05987488
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Mood (Psychological Function), Well Being
Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo.
- Conditions
- Mood (Psychological Function), Well Being, Mood, Healthy
- Trial name
- PRISMatic (NCT07610135)
- Testing
- Psilocybin, Pimavanserin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Healthy Volunteers
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
- Trial name
- NCT02419001
- Testing
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB
- Where
- 3 sites in United States, Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Respiratory Syncytial Virus (RSV)
A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
The goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable…
- Trial name
- NCT02289820
- Testing
- MEDI7510, IIV
- Where
- 5 sites in United States
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Male Pattern Hair Loss
Safety and Efficacy of HST 001 in Male Pattern Hair Loss
HST 001 (also known as hair stimulating complex [HSC]) is a mixture of growth factors secreted by human dermal fibroblasts when cultured in proprietary bioreactors which are then harvested and concentrated to specific ranges.
- Trial name
- NCT04435847
- Testing
- HST 001, Phosphate Buffered Saline
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Histogen