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

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

February 6, 2023

Primary Completion Date

April 17, 2024

Study Completion Date

August 2, 2025

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.

Trial Locations (1)

255499

PKU Care Luzhong Hospital, Zibo

All Listed Sponsors
collaborator

Peking University Care Luzhong Hospital

OTHER

lead

ScinnoHub Pharmaceutical Co., Ltd.

INDUSTRY