NCT06947109

A Clinical Study of AK139 in Healthy Subjects

A Phase I Clinical Study on Dose Escalation Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of AK139 in Healthy Subjects.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.

Detailed description

This is a phase I, dose escalation clinical study aimed to evaluate the safety, tolerability, PK and PD of AK139 in healthy subjects. This study will be conducted in a dose escalation design, sequentially increasing the dosage of the drug from low to high to complete a single subcutaneous dose escalation.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Placebo	Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
DRUG	AK111	The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed.

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: China