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

NCT07432698 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

  • Healthy Participants

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

Sponsors & Collaborators

  • Ark Biosciences Pty Ltd.

    collaborator UNKNOWN

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432698 on ClinicalTrials.gov