Clinical Trials in China / NCT07729839
Recruiting
Phase 1
Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
NCT07729839 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy Adult Participants
Investigational drug(s) / intervention(s)
ADB116 for InjectionPlacebo for ADB116 for Injection
ADB116 for Injection: ADB116 for Injection, single intravenous bolus injection
Placebo for ADB116 for Injection: Matching placebo, single intravenous bolus injection
Study 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 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.
Primary outcome measure(s)
- Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Safety and tolerability assessed by the frequency, relationship to treatment, severity (using CTCAE criteria, if applicable), seriousness, and expectedness of TEAEs, including adverse drug reactions (ADRs), Grade ≥3 AEs, serious adverse events (SAEs), serious adverse drug reactions (SADRs), AEs leading to treatment interruption, and AEs leading to premature study withdrawal. - Pharmacokinetic (PK) parameters：Cmax — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Cmax is defined as the highest concentration of the drug reached in the body (usually in plasma, whole blood, or serum) after administration. - Pharmacokinetic (PK) parameters： AUC0-t — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Area under the plasma concentration-time curve from time zero to the last measurable concentration - Pharmacokinetic (PK) parameters： AUC0-∞ — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Area under the plasma concentration-time curve from time zero extrapolated to infinity - Pharmacokinetic (PK) parameters：t1/2 — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
The time required for the concentration of a drug in the body (typically in plasma) to decrease by one-half. - Pharmacokinetic (PK) parameters：Vz/F — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
The theoretical volume in which the total amount would need to be uniformly distributed to produce the observed plasma concentration - Pharmacokinetic (PK) parameters：CL/F — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability (F). It reflects the efficiency of drug elimination following extravascular administration. - Pharmacokinetic (PK) parameters：λz — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Terminal elimination rate constant - Pharmacokinetic (PK) parameters：percentage of AUC extrapolated (AUC_%Extrap) — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Percentage of AUCinf due to extrapolation from Tlast to infinity - Pharmacokinetic (PK) parameters： MRT0-t — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Mean residence time from time zero to the last measurable concentration - Pharmacokinetic (PK) parameters： MRT0-∞ — From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)
Mean residence time from time zero extrapolated to infinity
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| NanFang Hospital of Southern Medical University | Guangzhou | Guangdong | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07729839 on ClinicalTrials.gov ↗ ← All trials in China