Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: ADB116 for Injection; Drug: Placebo for 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 26 healthy adults will be enrolled across 5 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 2-5: 0.06, 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
• Enrollment (Estimated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xinmin Yun, Ph.D; Phone Number: ＋86 0514-87752666; Email: yunxm@aidea.com.cn
• Study Contact Backup: Name: Bing Yang, M.Sc; Phone Number: ＋86 025-83193180; Email: yangbing@aidea.com.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • NanFang Hospital of Southern Medical University
      • Contact: Zhongyuan Xu, Ph.D.; Phone Number: +86 13926186470; Email: nflcyljd@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohor1: ADB116 0.03 mg/kg; ADB116 for Injection 0.03mg/kg, single intravenous bolus injection	Drug: ADB116 for Injection; ADB116 for Injection, single intravenous bolus injection; Other Names: ADB116
Experimental: Cohor 2: ADB116 0.06 mg/kg; ADB116 for Injection 0.06mg/kg, single intravenous bolus injection	Drug: ADB116 for Injection; ADB116 for Injection, single intravenous bolus injection; Other Names: ADB116; Drug: Placebo for ADB116 for Injection; Matching placebo, single intravenous bolus injection
Experimental: Cohor 3: ADB116 0.12mg/kg; ADB116 for Injection 0.12mg/kg, single intravenous bolus injection	Drug: ADB116 for Injection; ADB116 for Injection, single intravenous bolus injection; Other Names: ADB116; Drug: Placebo for ADB116 for Injection; Matching placebo, single intravenous bolus injection
Experimental: Cohor 4: ADB116 0.18mg/kg; ADB116 for Injection 0.18mg/kg, single intravenous bolus injection	Drug: ADB116 for Injection; ADB116 for Injection, single intravenous bolus injection; Other Names: ADB116; Drug: Placebo for ADB116 for Injection; Matching placebo, single intravenous bolus injection
Experimental: Cohor 5: ADB116 0.24 mg/kg; ADB116 for Injection 0.24 mg/kg， single intravenous bolus injection	Drug: ADB116 for Injection; ADB116 for Injection, single intravenous bolus injection; Other Names: ADB116; Drug: Placebo for ADB116 for Injection; Matching placebo, single intravenous bolus injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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.	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	The theoretical volume in which the total amount would need to be uniformly distributed to produce the observed plasma concentration	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	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.	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	Terminal elimination rate constant	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)	Percentage of AUCinf due to extrapolation from Tlast to infinity	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	Mean residence time from time zero to the last measurable concentration	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-∞	Mean residence time from time zero extrapolated to infinity	From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coagulation function parameters：thrombin time (TT)	Changes from baseline in thrombin time (TT)	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)	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)	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)	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)	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	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.	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	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	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	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	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	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	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	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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)	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.	From the date of first study drug administration to the End of Study visit (defined as 8 days after last dose)

Collaborators and Investigators

• Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Zhongyuan Xu, Ph.D., Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: ADYY-ADB116-101; CTR20260342 (Registry Identifier: chinadrugtrials.org.cn)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No