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A Clinical Study of BG136 Injection in Healthy Chinese Volunteers

NCT05984368 ↗

Phase 1 Unknown 74 enrolled The Affiliated Hospital of Qingdao University
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)

Timeline

Start
2023-08-18
Primary completion
2023-09-05
Completion
2024-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject BG136 Unknown 2 mg Intravenous
Subject BG136 Unknown 24 mg Intravenous
Subject BG136 Unknown 50 mg Intravenous
Subject BG136 Unknown 100 mg Intravenous
Subject BG136 Unknown 200 mg Intravenous
Subject BG136 Unknown 300 mg Intravenous
Subject BG136 Unknown 400 mg Intravenous

Indications

No indication recorded.