NCT07432698

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants

A Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of AK0406 in Healthy Adult Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a phase I, single-center, randomized, double-blind, placebo-controlled study of AK0406 as a first-in-human (FIH) trial to evaluate the safety, tolerability and pharmacokinetics (PK) of AK0406 in healthy adult participants.

Detailed description

This study consists of four cohorts: Cohort A: 150 milligram (mg) subcutaneous injection (s.c.) Cohort B: 300 mg s.c. Cohort C: 600 mg s.c. Cohort D: 900 mg s.c. Each cohort will enroll 8 healthy adult participants (AK0406: placebo = 3: 1), including both females and males. Dose escalation will follow a sequential order, beginning with the lowest dose 150 mg and proceeding to 300 mg, 600 mg, and finally 900 mg. A sentinel-dosing strategy will be implemented. For the first cohort (Cohort A) and the last cohort (Cohort D): the first two participants (1 AK0406, 1 placebo) will be dosed and observed for at least 7 days. The first two participants (1 AK0406, 1 placebo) in Cohort B and Cohort C will be dosed and observed for over 48 hours. After both the investigator and sponsor agree with the acceptable safety and tolerability profile, the remaining 6 participants (5 AK0406, 1 placebo) in that cohort will be dosed.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AK0406 150 mg	Single dose of AK0406 150 mg，subcutaneous injection
DRUG	AK0406 300 mg	Single dose of AK0406 300 mg，subcutaneous injection
DRUG	AK0406 600 mg	Single dose of AK0406 600 mg，subcutaneous injection
DRUG	AK0406 900 mg	Single dose of AK0406 900 mg，subcutaneous injection
DRUG	0.9% Sodium Chloride Injection as Placebo	0.9% Sodium Chloride Injection, subcutaneous injection

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Australia