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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants
Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
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
Conditions
Interventions
AK0406 150 mg
Single dose of AK0406 150 mg,subcutaneous injection
AK0406 300 mg
Single dose of AK0406 300 mg,subcutaneous injection
AK0406 600 mg
Single dose of AK0406 600 mg,subcutaneous injection
AK0406 900 mg
Single dose of AK0406 900 mg,subcutaneous injection
0.9% Sodium Chloride Injection as Placebo
0.9% Sodium Chloride Injection, subcutaneous injection
Locations (1)
Veritus Research
Bayswater, Victoria, Australia