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RECRUITING
NCT06996704
PHASE1

A Clinical Study of AK0610

Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-02-29

Completion Date

2025-09

Last Updated

2025-05-30

Healthy Volunteers

Yes

Interventions

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

Locations (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital )

Jinan, Shandong, China