Clinical Trial

Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

Recruiting Phase 1
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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.
Protocol Amendment History 4 changes
notable Enrollment increased: 26 -> 34 participants 2026-08-06
minor Trial arms changed: 5 -> 6 2026-08-06
notable Primary completion pushed: 2026-08-30 -> 2026-12-30 2026-08-06
minor Completion pushed: 2026-08-30 -> 2027-03-18 2026-08-06
Trial Details
NCT Number NCT07729839
Lead Sponsor Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Conditions Healthy Adult Participants
Enrollment 34 participants
Start Date 2026-05-31
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-03-18 (estimated)
Updated on ClinicalTrials.gov 2026-08-05