Clinical trials: Phase I
Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
- Trial name
- NCT05761301
- Testing
- ALN-KHK
- Where
- 15 sites in United States, Canada
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Healthy
Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.
- Trial name
- NCT00599001
- Testing
- SD-101
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Healthy
A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants
The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy…
- Trial name
- NCT05894928
- Testing
- LOXO-783, Cholestyramine
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Respiratory Syncytial Virus Infections
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.
- Trial name
- NCT02864628
- Testing
- MVA-BN-RSV
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Oral Ulcer, Oral Mucositis
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
The goal of this clinical trial is to learn if a new 1% Phenytoin mucoadhesive film is safe and works to treat oral ulcers in healthy adult volunteers and patients with oral ulcers.
- Conditions
- Oral Ulcer, Oral Mucositis, Aphthous Stomatitis
- Trial name
- PHENO-FILM (NCT07890428)
- Testing
- 1% Phenytoin Mucoadhesive Film, Blank Mucoadhesive Film
- Where
- Egypt
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Misr University for Science and Technology
Healthy Volunteers
Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses…
- Trial name
- NCT07787611
- Testing
- MWN109 tablet
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
HIV Infections
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another…
- Trial name
- NCT00076037
- Testing
- HIV CTL MEP administered with RC529-SE adjuvant, GM-CSF
- Where
- 7 sites in United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary Fibrosis, Tumor
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
- Trial name
- NCT05740475
- Testing
- 9MW3811 injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Fungal Infection
Safety and Pharmacokinetics of Rezafungin
This is a Phase 1, double-blind, placebo-controlled trial in three parts. A single ascending dose (SAD) study in six cohorts receiving a single subcutaneous (SC) dose of 1, 10, 30, 60, 100, or 200 mg of rezafungin; a multiple…
- Trial name
- NCT04117607
- Testing
- Rezafungin
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers
1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2.
- Trial name
- NCT05433844
- Testing
- Reference Drug or Test Drug
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical
HIV Infections
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of rgp120/HIV-1MN (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults.
PRIMARY: To examine the safety and potential improvement in immune responses elicited by combining rsgp120/HIV-1MN with the adjuvant QS-21.
- Trial name
- NCT00001044
- Testing
- Aluminum hydroxide, QS-21, rgp120/HIV-1MN
- Where
- 4 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)
This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older…
- Trial name
- NCT03293498
- Testing
- NanoFlu, Fluzone HD - Day 0, Fluzone HD - Day 21
- Where
- 3 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Novavax
Atopic Dermatitis
A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants…
- Trial name
- NCT05277571
- Testing
- UCB1381
- Where
- 16 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Influenza, H7N9 Influenza
Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil
The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .
- Trial name
- NCT03330899
- Testing
- H7N9 antigen + adjuvant IB160, H7N9 antigen + adjuvant SE, H7N9 antigen without adjuvant
- Where
- 3 sites in Brazil
- Volunteers
- 432 people, healthy volunteers welcome
- Sponsor
- Butantan Institute
Frailty
A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty
The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty.
- Trial name
- NCT06070532
- Testing
- Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
- Where
- The Bahamas
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cellcolabs Clinical LTD.
Healthy
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.
- Trial name
- NCT05249621
- Testing
- MZE001
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Maze Therapeutics
Chronic Obstructive Pulmonary Disease
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the…
- Trial name
- NCT01068184
- Testing
- AZD6553
- Where
- United Kingdom
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
HIV Infections
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules.
- Trial name
- NCT00001052
- Testing
- Aluminum hydroxide, QS-21, rgp120/HIV-1MN
- Where
- 5 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Evaluation of a Rotavirus Vaccine
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers.
- Trial name
- NCT02109484
- Testing
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg
- Where
- South Africa
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- PATH
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