Status:

RECRUITING

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

Lead Sponsor:

BioCryst Pharmaceuticals

Conditions:

Netherton Syndrome

Eligibility:

All Genders

12-65 years

Phase:

PHASE1

Brief 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...

Detailed 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 a...

Eligibility Criteria

Key Inclusion Criteria:

  • Male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (Parts 1 and 2), 18 to 65 years, inclusive (Part 3), or 12 to 65 years, inclusive (Part 4)
  • Confirmed diagnosis of Netherton syndrome (Parts 3 and 4)
  • IGA score of ≥ 3 (Parts 3 and 4) and IASI score of ≥ 16 (Part 4)
  • BMI between 18 and 30 kg/m^2, inclusive (Parts 1 and 2)
  • 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

Key Trial Info

Start Date :

September 26 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT06539507

Start Date

September 26 2024

End Date

December 1 2026

Last Update

March 31 2026

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Stanford University School of Medicine

Palo Alto, California, United States, 94304

2

Therapeutics Clinical Research

San Diego, California, United States, 92123

3

Yale Center for Clinical Investigation

New Haven, Connecticut, United States, 06519

4

Northwestern Dermatology CTU

Chicago, Illinois, United States, 60611

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