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

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

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.

Sponsors & Collaborators

• Peking University Care Luzhong Hospital

  collaborator OTHER

• ScinnoHub Pharmaceutical Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-06

Primary Completion

2024-04-17

Completion

2025-08-02

Countries

• China

Study Locations