Clinical trials: Phase 1b
Healthy Adult Volunteers
A MAD Study of TT301/MW189 in Healthy Volunteers
The purpose of this Study is to find out whether an investigational drug is safe and well tolerated. MW189 is being studied as a possible short-term treatment for people with different types of brain injury.
- Trial name
- NCT02942771
- Testing
- 0.075mg/kg TT301/MW189, 0.15mg/kg TT301MW189, 0.25mg/kg TT301/MW189
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Linda Van Eldik
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm…
- Trial name
- MEDI8897 1b (NCT02290340)
- Testing
- MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- MedImmune 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
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
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 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
Dyslipidemia
A Study of Evacetrapib in Participants With Abnormal Cholesterol
The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of…
- Trial name
- NCT02168803
- Testing
- Evacetrapib
- Where
- 3 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Covid19
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
- Trial name
- NCT04710303
- Testing
- hAd5-S-Fusion+N-ETSD vaccine
- Where
- South Africa
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Hepatitis B
Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.
- Trial name
- NCT05770895
- Testing
- GS-2829, GS-6779
- Where
- 9 sites in New Zealand, Taiwan
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-9 in Healthy Volunteers and Volunteers 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-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT04072861
- Testing
- RBT-9
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in…
- Conditions
- Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen, Healthy Volunteers
- Trial name
- NCT03290248
- Testing
- B244 suspension, Vehicle
- Where
- 2 sites in United States, Canada
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AOBiome LLC
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
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)
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
Influenza Vaccine
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50…
- Trial name
- NCT04785794
- Testing
- Sing2016 M2SR H3N2 influenza vaccine
- Where
- 3 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- FluGen Inc
Healthy Volunteers With Ileostomy
A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy
- Trial name
- NCT02473640
- Testing
- SYN-004, Esomeprazole, Ceftriaxone
- Where
- 2 sites in Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived…
- Trial name
- NCT03522506
- Testing
- TAK-925, Modafinil
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda