Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
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
Jiangsu Aidea Pharmaceutical Group Co., Ltd.
26 participants
May 31, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
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Interventions
ADB116 for Injection, single intravenous bolus injection
Matching placebo, single intravenous bolus injection
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07729839