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A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Sponsor: BioCryst Pharmaceuticals
Summary
This is a first-in-human, Phase 1/1b, 4-part study that includes the evaluation of safety, tolerability, pharmacokinetics (PK), and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult participants (Parts 1 and 2), and multiple doses in adult participants with Netherton syndrome (Part 3). In Part 4, the effectiveness, safety, and tolerability of BCX17725 when administered via multiple IV and/or SC doses through 12 weeks will be evaluated in adult and adolescent participants with Netherton syndrome.
Official title: A Phase 1/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of BCX17725 in Healthy Participants and Multiple Doses of BCX17725 in Participants With Netherton Syndrome
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2024-09-26
Completion Date
2026-12
Last Updated
2026-03-31
Healthy Volunteers
Yes
Conditions
Interventions
BCX17725
BCX17725 for injection
Placebo
Placebo for injection
Locations (12)
Stanford University School of Medicine
Palo Alto, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
Northwestern Dermatology CTU
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Westmead Hospital - Department of Dermatology
Sydney, New South Wales, Australia
Nucleus Network
Brisbane, Queensland, Australia
Veracity Clinical Research
Brisbane, Queensland, Australia
Hôpital Saint-Louis
Paris, France
Universitätsklinikum Heidelberg
Heidelberg, Germany
Maastricht Universitair Medisch Centrum (MUMC+)
Maastricht, Netherlands
Erasmus Universitair Medisch Centrum (EMC)
Rotterdam, Netherlands