NCT05032560

Safety and Pharmacokinetics Study in Healthy Japanese Volunteers

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of ABX464 Capsules in Healthy Japanese Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study consists of Part A, a randomized double-blind, single-ascending-dose study, and Part B, a randomized, double-blind, semi-sequential, escalating multiple-dose study, in healthy Japanese volunteers.

Detailed description

Part A includes the following two dose regimen groups: * 25 mg dose regimen group: ABX464 25 mg or placebo * 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Part B includes the following two dose regimen groups: * 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days * 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ABX464	Drug: ABX464 ABX464 is a new anti-inflammatory drug
DRUG	Placebo	Drug: Matching Placebo placebo matching with ABX464

Timeline

• Start date: 2021-09-27
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2021-09-02
• Last updated: 2023-01-26

Locations

1 site across 1 country: Japan