A Single Dose Study of SHR0410 in Healthy Male Participants

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.

Clinical Trial Description

Forty eight eligible participants will be enrolled into the 6 dose cohorts. For each cohort, a sentinel group of 2 subjects (1 receiving SHR0410 and 1 receiving placebo) will be dosed first (1:1 ratio). If no drug related adverse events occur in the sentinel participants, the remaining 6 subjects in a cohort will be dosed on the next day or later in a 5:1 ratio (5 subjects receiving SHR0410 and 1 subject receiving placebo). SHR0410 will be diluted in saline and administered as a 15 min constant dose IV infusion at a rate of 20 ml/hr on Day 1. ;

Study Design

Related Conditions & MeSH terms

Acute Pain

Clinical Trial Details

NCT number	NCT03493191
Study type	Interventional
Source	Atridia Pty Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	April 15, 2018
Completion date	July 14, 2018

View Details

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