Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

NCT07729839 | Recruiting Phase 1

• 2 other identifiers: ADYY-ADB116-101CTR20260342
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (31)

• Coagulation function parameters：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)

  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)

  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)

  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)

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

Study Arms (5)

Cohor1: ADB116 0.03 mg/kg

EXPERIMENTAL

ADB116 for Injection 0.03mg/kg, single intravenous bolus injection

Drug: ADB116 for Injection

Cohor 2: ADB116 0.06 mg/kg

EXPERIMENTAL

ADB116 for Injection 0.06mg/kg, single intravenous bolus injection

Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection

Cohor 3: ADB116 0.12mg/kg

EXPERIMENTAL

ADB116 for Injection 0.12mg/kg, single intravenous bolus injection

Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection

Cohor 4: ADB116 0.18mg/kg

EXPERIMENTAL

ADB116 for Injection 0.18mg/kg, single intravenous bolus injection

Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection

Cohor 5: ADB116 0.24 mg/kg

EXPERIMENTAL

ADB116 for Injection 0.24 mg/kg， single intravenous bolus injection

Drug: ADB116 for Injection; Drug: Placebo for ADB116 for Injection

Interventions

ADB116 for Injection DRUG

ADB116 for Injection, single intravenous bolus injection

Also known as: ADB116

Cohor 2: ADB116 0.06 mg/kg; Cohor 3: ADB116 0.12mg/kg; Cohor 4: ADB116 0.18mg/kg; Cohor 5: ADB116 0.24 mg/kg; Cohor1: ADB116 0.03 mg/kg

Placebo for ADB116 for Injection DRUG

Matching placebo, single intravenous bolus injection

Cohor 2: ADB116 0.06 mg/kg; Cohor 3: ADB116 0.12mg/kg; Cohor 4: ADB116 0.18mg/kg; Cohor 5: ADB116 0.24 mg/kg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Aidea Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Zhongyuan Xu, Ph.D.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: July 28, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)