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NCT Number: NCT07729839

Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

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.

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Zhongyuan Xu, Ph.D.

CONTACT

[email protected]

+86 13926186470

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADB116 for Injection

Drug

ADB116 for Injection, single intravenous bolus injection

Other names: ADB116

Placebo for ADB116 for Injection

Drug

Matching placebo, single intravenous bolus injection

Primary outcomes

  1. 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)

    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.

  2. 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)

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

  3. 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)

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

  4. 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)

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

  5. 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)

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

  6. 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)

    The theoretical volume in which the total amount would need to be uniformly distributed to produce the observed plasma concentration

  7. 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)

    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.

  8. 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)

    Terminal elimination rate constant

  9. 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)

    Percentage of AUCinf due to extrapolation from Tlast to infinity

  10. 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)

    Mean residence time from time zero to the last measurable concentration

  11. Pharmacokinetic (PK) parameters： MRT0-∞

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

    Mean residence time from time zero extrapolated to infinity

Secondary outcomes

  1. 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)

    Changes from baseline in thrombin time (TT)

  2. 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)

    Changes from baseline in activated partial thromboplastin time (APTT)

  3. 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)

    Changes from baseline in prothrombin time (PT)

  4. 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)

    Changes from baseline in fibrinogen (FIB)

  5. 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)

    Changes from baseline in fibrin/fibrinogen degradation products (FDP)

  6. 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)

    Changes from baseline in plasma D-dimer

  7. 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)

    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.

  8. 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)

    Heart rate in beat per minute

  9. 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)

    Changes in PR interval

  10. 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)

    Changes in QRS duration

  11. 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)

    Changes in QTc interval

  12. 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)

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

  13. Vital sign: pulse

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

    Pulse in beat per minute

  14. Vital sign: temperature

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

    Temperature in degree Celsius

  15. Physical examination:skin

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

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

  16. Physical examination: general appearance

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

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

  17. Physical examination:head

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

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

  18. Physical examination:eyes

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

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

  19. Physical examination: ears

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

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

  20. Physical examination:oral

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

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

  21. Physical examination:throat

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

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

  22. Physical examination:neck

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

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

  23. Physical examination:heart

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

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

  24. Physical examination:lungs

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

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

  25. Physical examination: extremities

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

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

  26. Physical examination: neuromuscular

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

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

  27. Physical examination: abdomen

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

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

  28. Clinical laboratory tests: hematology

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

    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.

  29. Clinical laboratory tests: urinalysis

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

    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.

  30. Clinical laboratory tests: fecal occult blood

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

    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)

  31. Clinical laboratory tests: blood chemistry

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bing Yang, M.Sc

CONTACT

[email protected]

＋86 025-83193180

Xinmin Yun, Ph.D

CONTACT

[email protected]

＋86 0514-87752666

Sponsors and collaborators

Lead sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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