Safety and tolerance of ADB116 for Injection in healthy adults
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
Run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. · NCT07729839 · Data updated 2026-11-12
This Phase 1 study tests whether a single IV dose of ADB116 is safe and well tolerated in healthy Chinese adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Jiangsu Aidea Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 31, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | March 18, 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07729839 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy Chinese adults aged 18 to 45 years, meeting weight, BMI, and health criteria.
✕Probably not a fit
Participants without appropriate safety signals or those who do not meet eligibility criteria may not see a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 trial conducted at a single center in Guangzhou. Seventy healthy adult volunteers will be screened and 34 will receive a single intravenous bolus of ADB116 or placebo across six dose levels (0.03 to 0.24 mg/kg) with safety and tolerability followed through Day 3, then a short follow-up through Day 8. The primary goal is to evaluate safety and tolerability; the secondary goal is to characterize the pharmacokinetic profile of a single IV dose. There are screening, treatment, and follow-up periods to monitor for adverse events and PK data.
Why it matters
Potential benefit: If successful, the study could support further development of ADB116 for possible future use.
How similar studies have gone: Phase 1 trials of similar intravenous agents commonly establish safety and PK in healthy volunteers; this study follows that established approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF) prior to any study procedures and be able to comply with the protocol requirements. 2. 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. 3. 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). 4. 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's running
-
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Zhongyuan Xu, Ph.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Xinmin Yun, Ph.D
- Email: yunxm@aidea.com.cn
- Phone: ＋86 0514-87752666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.