Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers

Summary

This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design

Conditions

• Healthy Volunteers

Interventions

DRUG

HSK21542

Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.

DRUG

HSK21542

Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

DRUG

HSK21542

Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Sichuan Haisco Pharmaceutical Group Co., Ltd

  lead INDUSTRY

Principal Investigators

• Min Yan, PhD · The Second Affiliated Hospital of Zhejiang University Medical College

• Hong-gang Lou, PhD · The Second Affiliated Hospital of Zhejiang University Medical College

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-09

Primary Completion

2020-09-06

Completion

2020-12-07

Countries

• China

Study Locations