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Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Summary
A Phase I Study of ADB116 for Injection in Healthy Chinese Adults. This study aims as follows: Primary Objective: • To evaluate the safety and tolerability of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults. Secondary Objective: • To evaluate the pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection.
Official title: Study of Safety, Tolerability, and Pharmacokinetics of ADB116 for Injection in Healthy Chinese Adults: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Phase I Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-05-31
Completion Date
2026-08-30
Last Updated
2026-07-28
Healthy Volunteers
Yes
Conditions
Interventions
ADB116 for Injection
ADB116 for Injection, single intravenous bolus injection
Placebo for ADB116 for Injection
Matching placebo, single intravenous bolus injection
Locations (1)
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China