Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Participants

In brief

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.

Key facts

Study ID

NCT07729839

Run by

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

People needed

34

Starts

2026-05-31

Expected to finish

2027-03-18

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Voluntarily sign the informed consent form (ICF) prior to any study procedures and be able to comply with the protocol requirements.
• Aged between 18 and 45 years (inclusive of 18 years up to but not including 46 years) at the time of signing the ICF, male or female.
• At screening, male subjects must weigh ≥50.0 kg, female subjects must weigh ≥45.0 kg, and body mass index (BMI) = weight (kg) / height² (m²) must be within the range of 19.0-26.0 kg/m² (inclusive).
• No history of major medical or surgical diseases prior to screening, and results of vital signs, physical examination, 12-lead ECG, laboratory tests, fundoscopic examination, chest X-ray, and abdominal ultrasound during the screening period must be normal or, if slightly outside the normal reference range, considered clinically insignificant by the investigator.

Where it is running

• NanFang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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