Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADB116 for Injection, Placebo for ADB116 for Injection.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
This trial is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose Phase I clinical trial conducted in healthy Chinese adults to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults.
A total of 34 healthy adults will be enrolled across 6 dose cohorts. For Cohort 1, ADB116 0.03 mg/kg (starting dose) will be administered as a single intravenous injection. Following safety and tolerability assessment, if the dose escalation stopping criteria are not met, the dose will be escalated sequentially using a modified Fibonacci method to Cohorts 2-6: 0.06, 0.09, 0.12, 0.18, and 0.24 mg/kg. After each dose level has been observed through the end of Day 3 (D3), and upon assessment by the sponsor and investigator confirming no safety concerns, the next dose cohort may proceed.
The study consists of three periods: a screening period (up to 28 days, D-28 to D-1), a treatment period (D1), and a follow-up period (D2 to D8). On the dosing day, a single intravenous bolus dose of ADB116 or placebo will be administered.
Interventions
- Drug ADB116 for Injection
ADB116 for Injection, single intravenous bolus injection - Drug Placebo for ADB116 for Injection
Matching placebo, single intravenous bolus injection
Primary outcome measures
- Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters：Cmax [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters： AUC0-t [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters： AUC0-∞ [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters：t1/2 [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters：Vz/F [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters：CL/F [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters：λz [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters：percentage of AUC extrapolated (AUC_%Extrap) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Pharmacokinetic (PK) parameters： MRT0-t [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
Secondary outcome measures (12)
- Coagulation function parameters：thrombin time (TT) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Coagulation function parameters：activated partial thromboplastin time (APTT) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Coagulation function parameters：prothrombin time (PT) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Coagulation function parameters：fibrinogen (FIB) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Coagulation function parameters：fibrin/fibrinogen degradation products (FDP) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Coagulation function parameters：plasma D-dimer [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Injection site reactions [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Electrocardiogram (ECG): heart rate [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Electrocardiogram (ECG): PR interval [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Electrocardiogram (ECG): QRS duration [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Electrocardiogram (ECG): QTc interval [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
- Vital sign: Sitting blood pressure (systolic and diastolic) [Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
Eligibility criteria
Inclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- NanFang Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT07729839 · ADYY-ADB116-101 · CTR20260342