Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects

Phase 1 Completed 84 enrolled ScinnoHub Pharmaceutical Co., Ltd. Peking University Care Luzhong Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.

Timeline

Start: 2023-02-06
Primary completion: 2024-04-17
Completion: 2025-08-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BT-114143	Unknown	0.03 mg/kg	—
Subject	BT-114143	Unknown	0.07 mg/kg	—
Subject	BT-114143	Unknown	0.15 mg/kg	—
Subject	BT-114143	Unknown	0.3 mg/kg	—
Subject	BT-114143	Unknown	0.6 mg/kg	—
Subject	BT-114143	Unknown	1.2 mg/kg	—
Subject	BT-114143	Unknown	2.4 mg/kg	—
Subject	BT-114143	Unknown	4.8 mg/kg	—
Subject	BT-114143	Unknown	8.4 mg/kg	—
Subject	BT-114143	Unknown	12.6 mg/kg	—
Subject	BT-114143	Unknown	15 mg/kg	—

Indications

No indication recorded.