NCT07729839 Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
| NCT ID | NCT07729839 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Aidea Pharmaceutical Group Co., Ltd. |
| Condition | Healthy Adult Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-05-31 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2026-05-31 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Zhongyuan Xu, Ph.D.
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT07729839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Adult Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07729839 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07729839 currently recruiting?
Yes, NCT07729839 is actively recruiting participants. Contact the research team at yunxm@aidea.com.cn for enrollment information.
Where is the NCT07729839 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07729839 clinical trial?
NCT07729839 is sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd.. The principal investigator is Zhongyuan Xu, Ph.D. at Nanfang Hospital, Southern Medical University. The trial plans to enroll 34 participants.