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

NCT06539507 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

BCX17725

BCX17725 for injection

DRUG

Placebo

Placebo for injection

Sponsors & Collaborators

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539507 on ClinicalTrials.gov