NCT06641388

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (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, 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 enrollment of approximately 180 healthy male participants from China.

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
DRUG	Ebronucimab	Ebronucimab subcutaneous injection
DRUG	Ebronucimab	Ebronucimab subcutaneous injection

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-04-30
• Completion: 2025-06-17
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China