NCT06996704

A Clinical Study of AK0610

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of AK0610 in Healthy Chinese Adults.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.

Detailed description

This study is a Phase I clinical trial that is randomized, double-blind, placebo-controlled, and involves single-dose administration, dose-escalation, and an expansion phase. It evaluates the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults. The study consists of two parts. The dose-escalation phase includes five cohorts (100 mg i.m.; 300 mg i.m.; 300 mg i.v.; 1000 mg i.v.; 3000 mg i.v.), each consisting of 8 individuals (AK0610: Placebo = 3:1), who are administered doses in sequential increments. Based on pharmacokinetic data, the dose-escalation phase will be expanded to include two additional dose cohorts (300 mg i.m.; 600 mg i.m.) of 48 individuals each (AK0610: Placebo = 3:1). Each participant will undergo a Screening Period from Day -29 to Day -1. They will receive one dose on Day 1, an Inpatient Observation Period from Day -1 to Day 8, and a Blinded Follow-Up Period from Day 9 to Day 181. Subjects in the AK0610 group will also enter an open-label period from Day 182 to Day 361.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	AK0610 Injection solution	Active Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.
DRUG	Placebo	Active Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: China