NCT05876767

Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants

A Randomized, Double-blind, Placebo-controlled Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Subcutaneous Doses of SAR444336 in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This phase 1 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a first step in clinical development prior to administering this new investigational medicinal product (IMP) to patients.

Detailed description

The anticipated study duration per participant is up to 10 weeks in Part 1. * Screening: 2 to 28 days prior to dosing (Day -28 to Day -2) * Treatment period: Day -1 to Day 29 post dose including * Institutionalization: Day -1 until Day 8 * Ambulant period including repeat PK and PD blood sampling and ambulant visits: Day 9 to Day 29 * Follow-up period: Day 30 to Day 43 The anticipated study duration per participant is up to 17 weeks in Part 2. * Screening: 2 to 28 days prior to dosing (Day -28 to Day -2) * Treatment period: Day -1 to Day 57 (Q2W/3 doses or Q4W/2 doses) or Day -1 to Day 85 (Q4W/3 doses), or Day -1 to Day 50 (Q3W) including * Institutionalization: Day -1 until Day 3 * Ambulant period including repeat PK and PD blood sampling, ambulant visits and 24 hours institutionalization after 2nd and/or 3rd dose: Day 4 to Day 57 (Q2W/3 doses, Q4W/2 doses), Day 4 to Day 85 (Q4W/3 doses) or Day 50 (Q3W) * Follow-up period: Day 58 to Day 71 (Q2W/3 doses or Q4W/2 doses), Day 71 to Day 85 (Q4W/3 doses) or Day 51 to Day 64 (Q3W)

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	SAR444336	Single or repeated dose subcutaneous injection
DRUG	Placebo	Single or repeated dose subcutaneous injection

Timeline

• Start date: 2021-10-15
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2023-05-25
• Last updated: 2025-09-16

Locations

2 sites across 1 country: Netherlands