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Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJiangsu Aidea Pharmaceutical Group Co., Ltd.

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • ADB116 for Injection

    Drug

    ADB116 for Injection, single intravenous bolus injection

  • Placebo for ADB116 for Injection

    Drug

    Matching placebo, single intravenous bolus injection

Treatment groups

34 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 1: ADB116 0.03 mg/kgExperimental treatment 1 intervention
Group B: Cohort 2: ADB116 0.06 mg/kgExperimental treatment 2 interventions
Group C: Cohort 4: ADB116 0.12mg/kgExperimental treatment 2 interventions
Group D: Cohort 5: ADB116 0.18mg/kgExperimental treatment 2 interventions
Group E: Cohort 6: ADB116 0.24 mg/kgExperimental treatment 2 interventions
Group F: Cohort 3: ADB116 0.09 mg/kgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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