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
Inclusion
- 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
Exclusion
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
October 30 2025
Active Locations (4)
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1
Investigative site
New Haven, Connecticut, United States, 06519
2
Investigative site
Indianapolis, Indiana, United States, 46250
3
Investigative site
Sydney, New South Wales, Australia
4
Investigative site
Brisbane, Queensland, Australia