Clinical trials: First in Man Study to Evaluate Initial Safety
Healthy Volunteers
First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
- Trial name
- NCT01011296
- Testing
- PF-04427429
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRS-080
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for treatment of anemia of…
- Trial name
- NCT02340572
- Testing
- PRS-080#022-DP
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pieris Pharmaceuticals GmbH
Hypercholesterolemia, Hyperlipoproteinemia Type II
Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects.
- Trial name
- NCT02100839
- Testing
- AEM-28, Normal Saline
- Where
- Australia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- LipimetiX Development, LLC
Depressive Disorder, Major
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects
This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally…
- Trial name
- SUVN-911 (NCT03155503)
- Testing
- SUVN-911
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Suven Life Sciences Limited
Group A Streptococcal Infection
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of VAX-A1 in healthy adults 18-40 years of age.
- Trial name
- NCT07616934
- Testing
- VAX-A1 Low, VAX-A1 Mid, VAX-A1 High
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus (RSV)
Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.
- Trial name
- EuRSV (NCT06216093)
- Testing
- EuRSV
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
Cardiovascular Diseases
A First-in-human Study of YN001 in Healthy Volunteers
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
- Trial name
- NCT05635084
- Testing
- YN001
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Beijing Inno Medicine Co., Ltd.
Parkinson Disease
First-in-Human Single and Multiple Dose of HL-400
This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 (a NLRP3 inhibitor) following oral single and multiple ascending…
- Trial name
- NCT06997484
- Testing
- HL-400
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Highlightll Pharmaceutical (USA) LLC
Healthy Volunteers
First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001
First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001
- Trial name
- NCT02110420
- Testing
- CC-90001
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Celgene Corporation
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.
Influenza
Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects
The present study is a first-in-man clinical trial evaluating OVX836, a recombinant broad spectrum vaccine for Influenza. This clinical trial will evaluate the safety and the immune response of increasing doses of OVX836 after…
- Trial name
- NCT03594890
- Testing
- OVX836 (Intramuscular), OVX836 (Intranasal)
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Osivax
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants
This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated.
- Trial name
- NCT03919409
- Testing
- TS-161
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical R&D Inc.
Healthy
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of JNJ-64179375 induced Pharmacodynamic effects on…
- Trial name
- NCT02949206
- Testing
- JNJ-64179375, 4 Factor Prothrombin Complex Concentrate (PCC)
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Chronic HBV Infection
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects.
- Trial name
- NCT04008004
- Testing
- EDP-514
- Where
- 15 sites in United States, Canada
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Healthy Participants
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
The purposes of this study are: To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth.
- Trial name
- NCT05890105
- Testing
- PF-07853578
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Participants Study
Phase 1 Study of PRX019 in Healthy Adult Volunteers
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
- Trial name
- NCT06699680
- Testing
- PRX019
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Prothena Biosciences Ltd.
Healthy Study Participants, Chronic Spontaneous Urticaria
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.
- Trial name
- NCT04444466
- Testing
- UCB8600
- Where
- Bulgaria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of…
- Trial name
- NCT04488705
- Testing
- ETD002 - single dose, ETD002 - 7 day repeat dose, ETD002 - 14 day repeat dose
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Covid19
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
- Trial name
- NCT04532294
- Testing
- BGB DXP593
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene