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

Last updated: October 2, 2024
Sponsor: BioCryst Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1

Condition

Ichthyosis

Treatment

BCX17725

Placebo

Clinical Study ID

NCT06539507
BCX17725-101
U1111-1303-9510
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a first-in-human, Phase 1/1b, 3-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 participants with Netherton Syndrome (Part 3).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (Parts 1 and 2) or aged 18 to 65 years, inclusive (Part 3)

  • Confirmed diagnosis of Netherton syndrome (Part 3 only)

  • BMI between 18 and 30 kg/m^2, inclusive (Parts 1 and 2 only)

  • Estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73 m^2 (Parts 1 and 2) or ≥ 60 mL/min/1.73 m^2 (Part 3)

  • Agree to follow the protocol contraception requirements from screening until 90 days after the last dose of study drug

  • In the opinion of the investigator, expected to adequately comply with all required study procedures and restrictions for the duration of the study

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: BCX17725
Phase: 1
Study Start date:
September 26, 2024
Estimated Completion Date:
July 31, 2025

Study Description

Parts 1 and 2 are randomized, placebo-controlled, single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study parts, respectively, in healthy participants. Part 3 will evaluate multiple dose administrations in participants with Netherton syndrome in an open-label design.

Connect with a study center

  • Investigative site

    Brisbane, Queensland
    Australia

    Active - Recruiting

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