Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

Phase 1RecruitingNCT07729839

Jiangsu Aidea Pharmaceutical Group Co., Ltd.34 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Adult Participants

Interventions

ADB116 for InjectionDRUG

ADB116 for Injection, single intravenous bolus injection

Placebo for ADB116 for InjectionDRUG

Matching placebo, single intravenous bolus injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Frequency of Treatment-emergent Adverse Events (TEAEs) following a single dose of ADB116 for injection

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.

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

Cmax is defined as the highest concentration of the drug reached in the body (usually in plasma, whole blood, or serum) after administration.

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

Area under the plasma concentration-time curve from time zero to the last measurable concentration

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-∞

Area under the plasma concentration-time curve from time zero extrapolated to infinity

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

The time required for the concentration of a drug in the body (typically in plasma) to decrease by one-half.

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

Central Contacts

Xinmin Yun, Ph.D

CONTACT

＋86 0514-87752666 yunxm@aidea.com.cn

Bing Yang, M.Sc

CONTACT

＋86 025-83193180 yangbing@aidea.com.cn

Data from ClinicalTrials.gov

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Secondary Outcomes

Coagulation function parameters：thrombin time (TT)

Changes from baseline in 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)

Changes from baseline in 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)

Changes from baseline in 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)

Changes from baseline in 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)

Changes from baseline in 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

Changes from baseline in 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

Incidence and severity of local injection site reactions, assessed by the presence of pain, tenderness, erythema (redness), and induration (nodules/swelling) at the injection site.

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

Heart rate in beat per minute

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

Changes in 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

Changes in 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

Changes in 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)

Systolic and diastolic blood pressure in millimeters (mm) of mercury (Hg)Time

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: pulse

Pulse in beat per minute

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: temperature

Temperature in degree Celsius

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:skin

Clinically significant changes from baseline in skin examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination: general appearance

Clinically significant changes from baseline in general appearance examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:head

Clinically significant changes from baseline in head examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:eyes

Clinically significant changes from baseline in eyes examination, categorized as medical history, AE, or other

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination: ears

Clinically significant changes from baseline in ears examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:oral

Clinically significant changes from baseline oral appearance examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:throat

Clinically significant changes from baseline in throat examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:neck

Clinically significant changes from baseline in neck examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:heart

Clinically significant changes from baseline in heart examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination:lungs

Clinically significant changes from baseline in lungs examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination: extremities

Clinically significant changes from baseline in extremities examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination: neuromuscular

Clinically significant changes from baseline in neuromuscular examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Physical examination: abdomen

Clinically significant changes from baseline in abdomen examination, categorized as medical history, AE, or other.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Clinical laboratory tests: hematology

Changes in hematology parameters, including eosinophil percentage, basophil percentage, neutrophil percentage, lymphocyte percentage, monocyte percentage, eosinophil count, basophil count, neutrophil count, lymphocyte count, monocyte count, white blood cell count, red blood cell count, platelet count, hematocrit, and hemoglobin, findings are reported as presence or absence of clinically significant change from baseline.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Clinical laboratory tests: urinalysis

Changes in urinalysis parameters, including white blood cells, red blood cells, pH, protein, glucose, and ketones. This outcome is not measured on a scale; findings are reported as presence or absence of clinically significant change from baseline.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Clinical laboratory tests: fecal occult blood

Changes in fecal occult blood test results. Qualitative test; findings are reported as presence or absence of clinically significant change from baseline. (negative to positive shift, or vice versa)

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Clinical laboratory tests: blood chemistry

Changes in blood chemistry parameters, including ALT, AST, alkaline phosphatase, GGT, LDH, glucose, total protein, albumin, total bilirubin, direct bilirubin, urea, creatinine, potassium, sodium, amylase, and lipase. Findings are reported as presence or absence of clinically significant change from baseline.

Time frame: From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)