NCT07169240

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: ScinnoHub Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 0.03 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 0.07 mg/kg.
DRUG	BT-114143	3 subjects will receive a single dose of BT-114143 injection at 0.15 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 0.3 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 0.6 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 1.2 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 2.4 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 4.8 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 8.4 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 12.6 mg/kg.
DRUG	BT-114143	6 subjects will receive a single dose of BT-114143 injection at 15 mg/kg.
DRUG	0.9% Sodium Chloride Injection as Placebo	Except that the S1 dose group was a pilot study group with 1 subject matched to receive a placebo, all other dose groups were each matched with 2 subjects who received placebo treatment as controls.

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-04-17
• Completion: 2025-08-02
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China