A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725

Part of paid clinical trials in Palo Alto, California.

Sponsor
BioCryst Pharmaceuticals
Study ID
NCT06539507
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Netherton Syndrome

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • BCX17725 — DRUG
    BCX17725 for injection
  • Placebo — DRUG
    Placebo for injection

Study Details

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.

Key Dates

Start date
Sep 26, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - BCX17725 single dose
    Participants randomized to BCX17725 will receive BCX17725 as a single dose in sequential ascending dose cohorts
  • Experimental: Part 1 - placebo single dose
    Participants randomized to placebo will receive placebo as a single dose
  • Experimental: Part 2 - BCX17725 multiple doses
    Participants randomized to BCX17725 will receive BCX17725 as multiple doses in sequential ascending dose cohorts
  • Experimental: Part 2 - placebo multiple doses
    Participants randomized to placebo will receive placebo as multiple doses
  • Experimental: Part 3 - BCX17725 multiple doses
    Participants will receive BCX17725 as multiple doses
  • Experimental: Part 4 - BCX17725 multiple doses
    Participants will receive BCX17725 as multiple doses

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From screening through EOS (ie, through Day 78 in Parts 1 and 3, and Day 106 in Part 2) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94304
Chaw-Ning Lee
[email protected]
650-497-7230
Thomas Buschbacher
[email protected]
352-278-7603
Therapeutics Clinical ResearchSan DiegoCalifornia92123
Hector Bailon
[email protected]
858-571-6800
Yale Center for Clinical InvestigationNew HavenConnecticut06519
Nicole Olszewski
[email protected]
203-785-5505
Northwestern Dermatology CTUChicagoIllinois60611
[email protected]
312-503-5944
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250
Joannie Prusa
[email protected]
317-516-5030

Find similar trials in Palo Alto, CA

By research site
Stanford University School of Medicine· Palo Alto, CATherapeutics Clinical Research· San Diego, CAYale Center for Clinical Investigation· New Haven, CTNorthwestern Dermatology CTU· Chicago, ILDawes Fretzin Clinical Research Group, LLC· Indianapolis, IN

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