An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
NCT03240809 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2025-09-16
Summary
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects
Conditions
Interventions
- BIOLOGICAL
-
Brodalumab
140 mg SC dose
- BIOLOGICAL
-
Brodalumab
70 mg SC dose
Sponsors & Collaborators
-
Bausch Health Americas, Inc.
lead INDUSTRY
Principal Investigators
-
Varsha Bhatt · Bausch Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-24
- Primary Completion
- 2028-12-31
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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