Actively Recruiting
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Led by BioCryst Pharmaceuticals · Updated on 2026-03-31
78
Participants Needed
12
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-lactating female aged 18 to 55 years (Parts 1 and 2), 18 to 65 years (Part 3), or 12 to 65 years (Part 4)
- Confirmed diagnosis of Netherton syndrome (Parts 3 and 4)
- IGA score of 3 or higher (Parts 3 and 4)
- IASI score of 16 or higher (Part 4)
- Body mass index between 18 and 30 kg/m² (Parts 1 and 2)
- Estimated glomerular filtration rate of at least 90 mL/min/1.73 m² (Parts 1 and 2) or at least 60 mL/min/1.73 m² (Part 3)
- Agree to follow contraception requirements from screening until 90 days after last dose
- Expected to comply with all study procedures and restrictions for study duration
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
Actively Recruiting
3
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06519
Actively Recruiting
4
Northwestern Dermatology CTU
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
6
Westmead Hospital - Department of Dermatology
Sydney, New South Wales, Australia, 2145
Actively Recruiting
7
Nucleus Network
Brisbane, Queensland, Australia, 4006
Active, Not Recruiting
8
Veracity Clinical Research
Brisbane, Queensland, Australia, 4102
Actively Recruiting
9
Hôpital Saint-Louis
Paris, France, 75010
Not Yet Recruiting
10
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
11
Maastricht Universitair Medisch Centrum (MUMC+)
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
12
Erasmus Universitair Medisch Centrum (EMC)
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
Research Team
B
BioCryst Pharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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