NCT07043283

A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects

A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Healthy Male Chinese Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Akeso · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.

Detailed description

This is a randomized, double-blind, parallel controlled, phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects. This study consists of two parts: pre-trial part and formal-trial part; with a planned sample size of 36 subjects in the pre-trial part, and 168 subjects in the formal trial part. A total of approximately 204 Chinese healthy male subjects are planned to be enrolled.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ebronucimab	Ebronucimab subcutaneous injection.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: China