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NCT06539507 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
A Phase 1 study of Netherton Syndrome, sponsored by BioCryst Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 12
- Study locations
NCT06539507: Recruiting Phase 1 study of Netherton Syndrome, sponsored by BioCryst Pharmaceuticals.
NCT06539507 is a Phase 1 study of Netherton Syndrome that is actively recruiting participants, run by BioCryst Pharmaceuticals. The registered enrollment target is 78 participants, above the 16-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (388% higher). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06539507, a Phase 1 study of Netherton Syndrome, is actively recruiting participants, sponsored by BioCryst Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
Incidence of TEAEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) from screening through end-of-study (EOS) in each study part
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BCX17725
Study Locations (12)
Other
- Hôpital Saint-Louis - Paris
- Universitätsklinikum Heidelberg - Heidelberg
- Maastricht Universitair Medisch Centrum (MUMC+) - Maastricht
- Erasmus Universitair Medisch Centrum (EMC) - Rotterdam
California
- Stanford University School of Medicine - Palo Alto
- Therapeutics Clinical Research - San Diego
Queensland
- Nucleus Network - Brisbane
- Veracity Clinical Research - Brisbane
Connecticut
- Yale Center for Clinical Investigation - New Haven
Illinois
- Northwestern Dermatology CTU - Chicago
Indiana
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis
New South Wales
- Westmead Hospital - Department of Dermatology - Sydney
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT06539507 shows while recruiting
NCT06539507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 16-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (388% higher).
The record links to 1 condition, with Netherton Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06539507 lists 12 locations in 7 states (Other, California, Queensland).
Frequently Asked Questions
What is clinical trial NCT06539507 about?
NCT06539507 is a clinical study titled "A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725". 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 ...
What is the current status of trial NCT06539507?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2024-09-26. Estimated completion is 2026-12.
What conditions does trial NCT06539507 study?
This clinical trial studies the following conditions: Netherton Syndrome.
What interventions are being tested in trial NCT06539507?
The interventions under investigation include: Placebo (DRUG), BCX17725 (DRUG).
Who is sponsoring clinical trial NCT06539507?
This trial is sponsored by BioCryst Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06539507 being conducted?
This trial has 12 study locations across California, Connecticut, Illinois, Indiana, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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