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NOT YET RECRUITING
NCT07432698
PHASE1

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

Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-02

Completion Date

2027-04

Last Updated

2026-02-25

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Veritus Research

Bayswater, Victoria, Australia