Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

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

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

Treatments tested in this trial

  • ADB116 for Injection
  • Placebo for ADB116 for Injection

Treatment groups

34 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.