Clinical trials: Phase 1b
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 A
Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03999554
- Testing
- LD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine, HD Sing2016 M2SR H3N2 influenza vaccine
- Where
- 4 sites in United States
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- FluGen Inc
Pain, Cancer
Study on Analgesia of GIC-1001 & GIC-1002 on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method
This study evaluates colonic analgesia by comparing two novel formulations, GIC-1001 and GIC-1002 with placebo using a barostat distender.
- Conditions
- Pain, Cancer, Colonic Disease
- Trial name
- NCT02276768
- Testing
- GIC-1001 375 mg TID, GIC-1001 500 mg TID, GIC-1002 345 mg TID (equimolar to GIC-1001 375 mg TID)
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- gicare Pharma Inc.
Influenza
Study of Safety and Immunogenicity of a Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years
One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for safety and immunogenicity in healthy adults 65 to 75…
- Trial name
- NCT02247362
- Testing
- VAX2012Q
- Where
- 3 sites in Australia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- VaxInnate Corporation
Covid19
Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a
VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing…
- Trial name
- NCT04773665
- Testing
- VBI-2902a, VBI-2905a
- Where
- 4 sites in Canada
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Olmsted Syndrome
Study of KM-023 in Healthy Volunteers and Patients With Olmsted Syndrome.
The trial is conducted in order to assess the safety of KM-023 and to observe what effects, both beneficial and adverse, it has on the body, and the way the body absorbs and eliminates KM-023, first in healthy participants, then…
- Trial name
- NCT07090889
- Testing
- KM-023
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Orvida Pharma (formerly Kamari Pharma)
Schistosomiasis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the rSm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar
The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given…
- Trial name
- NCT05762393
- Testing
- rSm-p80 + GLA-SE
- Where
- 2 sites in Burkina Faso, Madagascar
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT06195891
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Healthy Adult Immune Responses to Vaccine
VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults
Background: Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola.
- Trial name
- NCT02408913
- Testing
- VRC-EBOMVA079-00-VP (MVA-EbolaZ), VRC-EBOADC069-00-VP (cAd3-EBO)
- Where
- 3 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Aging
aKLmRNA-mediated Protein Replacement Therapy
This is a Phase 1b randomized, double-blind, placebo-controlled study to assess the safety and tolerability of a proprietary aKLmRNA formulated in lipid nanoparticles. Approximately 21 subjects will be enrolled.
- Trial name
- NCT07544420
- Testing
- aKLmRNA (AKL003)
- Where
- Honduras
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Klothea Bio Inc
Atopic Immunoglobulin E-Mediated Allergic Disorder
A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
- Trial name
- NCT03819881
- Testing
- STMC-103H
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Siolta Therapeutics, Inc.
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)
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB)…
- Trial name
- NCT07709494
- Testing
- Rev-56 for Inhalation
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Revagenix, 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.
Healthy Adult Immune Responses to Vaccine
Safety, Tolerability, and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO), VRC-EBOADC069-00-VP, in Healthy Adults
Background: Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever.
- Trial name
- NCT02231866
- Testing
- VRC-EBOADC069-00-VP, VRC-EBOADC076-00-VP
- Where
- 3 sites in United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Phase 1b Influenza Vaccine Study in Healthy Subjects
The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects.
- Trial name
- NCT01181336
- Testing
- Influenza vaccine (FLU-v), FLU-v Control
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- PepTcell Limited
Acute Kidney Injury
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.
- Trial name
- NCT03630029
- Testing
- FeS and SnPP
- Volunteers
- healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Infectious Disease, COVID-19
Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Individuals
Phase 1b, randomized, open-label, study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 only, RVM-V002 only, or RVM V001 + RVM V002 (Co administered as Separate Injections) in healthy adults.
- Trial name
- NCT05788185
- Testing
- RVM-V001 30 µg, RVM-V002 30 µg, RVM-V001 (15 µg) + RVM-V002 (15 µg) co-administration
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- RVAC Medicines (US), Inc.
Malaria,Falciparum
Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso
This clinical trial aims to learn about the safety and immunogenicity of the blood-stage malaria vaccine candidate SUM-101 in infants and children, paving the way for its incorporation into a multi-stage malaria vaccine.
- Trial name
- SUM-101 (NCT06618885)
- Testing
- SUM-101
- Where
- Burkina Faso
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- European Vaccine Initiative
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