NCT06326814

A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults

A First-in-human, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single Doses of SAR443809 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary objective * The tolerability and safety of SAR443809 Secondary * The PK parameters of SAR443809 * The PD activity of SAR443809 * The immunogenicity of SAR443809

Detailed description

Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
DRUG	Humanized anti-Factor Bb monoclonal antibody	Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
DRUG	Placebo	Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Timeline

• Start date: 2021-10-11
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study