Clinical trials: Phase 1b
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
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
Norovirus
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988.
- Trial name
- NCT07198139
- Testing
- CDI-988, Snow Mountain Virus
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cocrystal Pharma, Inc.
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.
Atopic Dermatitis
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
- Trial name
- NCT03431610
- Testing
- SB414 2%, SB414 6%, Vehicle
- Where
- 9 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novan, Inc.
Healthy Subjects
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Oral EC5026 in Healthy Subjects
EC5026 has been shown to be effective in preclinical pain models of pain, including inflammatory and neuropathic pain subtypes. Two Phase 1a studies - a Phase 1a single ascending dose (SAD) study and a Phase 1a fed-fasted study …
- Trial name
- NCT06089837
- Testing
- EC5026 oral tablet
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- EicOsis Human Health Inc.
Kidney Disease
A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease
This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given.
- Trial name
- NCT06734234
- Testing
- GSK4771261
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
COVID-19
A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19
This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months…
- Trial name
- NCT05396573
- Testing
- RQ3013, Comirnaty
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Walvax Biotechnology Co., Ltd.
Chronic Anal Fissure
E-CEL UVEC Treatment for Anal Fissures
This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure.
- Trial name
- NCT06456073
- Testing
- E-CEL UVEC cells (AB-207)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
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
Healthy
1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
- Trial name
- NCT04589403
- Testing
- OPT101
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Op-T LLC
Influenza
Seasonal Influenza HA DNA With Trivalent Inactivated Vaccine (TIV) Administered ID or IM in Healthy Adults 18-70 Years
This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety, tolerability, and immunogenicity of same season and sequential season vaccination schedules consisting of the 2012/2013 seasonal influenza DNA…
- Trial name
- NCT01676402
- Testing
- Seasonal Influenza DNA vaccine, TIV
- Where
- 4 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Memory Disorders
AIT-082 Phase 1B Study
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain.
- Trial name
- NCT00000180
- Testing
- AIT-082
- Where
- 4 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Pharmacokinetics
Oral Nafamostat in Healthy Volunteers (NAF-101)
This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d..
- Trial name
- NCT04406415
- Testing
- Nafamostat Mesilate
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Ensysce Biosciences
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)
Respiratory Syncytial Virus Infections
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose.
- Trial name
- NCT04444284
- Testing
- Investigational RSV vaccine MV-012-968 (Dosage 1), Investigational RSV vaccine MV-012-968 (Dosage 2), Investigational RSV vaccine MV-012-968 (Dosage 3)
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Meissa Vaccines, Inc.
HIV Infections
Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults
Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus).
- Trial name
- NCT00961883
- Testing
- NYVAC-B, rAd5
- Where
- 2 sites in Switzerland
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
HIV Infections
Evaluating the Safety and Immune Response to Five Different Combinations of HIV Vaccines in Healthy, HIV-Uninfected Adults
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.
- Trial name
- NCT01964937
- Testing
- DNA-HIV-PT123, NYVAC-HIV-PT1, NYVAC-HIV-PT4
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Phase 1b Malaria Clinical Trial Using Argemone Mexicana in Healthy Adults in Mali
The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.
- Trial name
- NCT01645254
- Testing
- Argemone mexicana
- Where
- Mali
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Bamako