A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.
NCT05976373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2023-08-04
Summary
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Dupilumab (SAR231893)
injection solution subcutaneous
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-05
- Primary Completion
- 2015-03-30
- Completion
- 2015-03-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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