Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат ADB116 for Injection
  ADB116 for Injection, single intravenous bolus injection
• Препарат Placebo for ADB116 for Injection
  Matching placebo, single intravenous bolus injection

Первичные конечные точки

• Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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-∞ [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]

Вторичные конечные точки (12)

• Coagulation function parameters：thrombin time (TT) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]
• Injection site reactions [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• NanFang Hospital of Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07729839 · ADYY-ADB116-101 · CTR20260342

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• NMPA/CDE CTR20260342 (платформа chinadrugtrials.org.cn)

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