Clinical trials: First in Man Study to Evaluate Initial Safety
Healthy Volunteers
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
- Trial name
- NCT03055403
- Testing
- M201-A Injection
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Yuji KUMAGAI
Healthy Subjects
A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects
This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.
- Trial name
- NCT02316756
- Testing
- PF-06648671
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Participants
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral…
- Trial name
- NCT04124653
- Testing
- PF-06842874, Relative Bioavailability
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Pfizer
Typhoid Fever
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK).
- Trial name
- NCT05613205
- Testing
- TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine, TYP03A Low Dose with Alum investigational vaccine
- Where
- Belgium
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atopic Dermatitis
A First-in-Human Study of QY211 Gel in Adult Subjects
This is a phase Ia/Ib,Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of…
- Trial name
- NCT05843422
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
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.
Hereditary Angioedema
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and…
- Trial name
- NCT02448264
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Herpes Simplex
A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI).
- Trial name
- NCT05298254
- Testing
- Non-adjuvanted HSV formulation 1, Non-adjuvanted HSV formulation 2, Non-adjuvanted HSV formulation 3
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 505 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
- Trial name
- NCT07422207
- Testing
- ME3241
- Where
- Australia
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Meiji Pharma USA Inc.
Healthy Volunteers - Male and Female
A Phase I Trial of Subcutaneous QLS7305 in Healthy Adults
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China.
- Trial name
- NCT07313150
- Testing
- QLS7305 Injection
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy Volunteers, Propionic Acidemia
A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia
The purpose of this study is to assess the safety, tolerability, PK and PD of BBP-671 in healthy volunteers and patients with Propionic Acidemia or Methylmalonic Acidemia.
- Conditions
- Healthy Volunteers, Propionic Acidemia, Methylmalonic Acidemia, Organic Acidemia
- Trial name
- NCT04836494
- Testing
- BBP-671
- Where
- 3 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- CoA Therapeutics, Inc., a BridgeBio company
Systemic Lupus Erythematosus
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants
This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated…
- Trial name
- NCT06188507
- Testing
- GSK4347859
- Where
- 2 sites in United Kingdom
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and…
- Trial name
- NCT04926701
- Testing
- ETD001 single dose, ETD001 multiple twice daily doses, ETD001 multiple once daily doses
- Where
- United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Anemia, Chronic Diseases
First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94
This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in patients with anemia of chronic disease…
- Conditions
- Anemia, Chronic Diseases, Inflammation
- Trial name
- NCT01372137
- Testing
- NOX-H94, Glucose 5%
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- TME Pharma AG
Plaque Psoriasis
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.
- Trial name
- NCT03210961
- Testing
- PF-06826647 tablet, PF-06826647 oral suspension
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers (HV), Skin Irritation
Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use
This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers.
- Trial name
- EV-MELSAFE (NCT07707986)
- Testing
- Exosome-Containing Liquid, Vehicle Liquid
- Where
- Kazakhstan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- West Kazakhstan Marat Ospanov Medical University
Malaria, Falciparum
First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults
This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.
- Trial name
- NCT07646353
- Testing
- GSK4425689A SC, GSK4425689A IV
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
- Trial name
- NCT04223960
- Testing
- EA1080
- Where
- United Kingdom
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- EA Pharma Co., Ltd.
Malaria, Falciparum
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
- Trial name
- NCT06171113
- Testing
- GSK4024484C
- Where
- United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Depressive Disorder and Anxiety Disorders
First Study in Humans With GSK424887
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body…
- Trial name
- NCT01059591
- Testing
- GSK424887, PET
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline