Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection
Recruiting
Phase 1
Interventional Study
Healthy Adult Participants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 34 (estimated)
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
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 …
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