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Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

NCT07729839 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-08-05

No results posted yet for this study

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

Interventions

DRUG

ADB116 for Injection

ADB116 for Injection, single intravenous bolus injection

DRUG

Placebo for ADB116 for Injection

Matching placebo, single intravenous bolus injection

Sponsors & Collaborators

  • Jiangsu Aidea Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhongyuan Xu, Ph.D. · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-30
Completion
2027-03-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729839 on ClinicalTrials.gov