RecruitingPhase 1NCT06996704

A Clinical Study of AK0610

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.

Sponsor

Shanghai Ark Biopharmaceutical Co., Ltd.

Enrollment

136 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer Study

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AK0610 Injection solution and a drug called Placebo for people with healthy volunteer study. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK0610 Injection solution

Active Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06996704

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