NCT03493191

A Single Dose Study of SHR0410 in Healthy Male Participants

A Phase I, Randomized, Double-blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SHR0410 in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	0.5μg/kg SHR0410	a single dose of 0.5μg/kg SHR0410
DRUG	1μg/kg SHR0410	a single dose of 2μg/kg SHR0410
DRUG	2μg/kg SHR0410	a single dose of 2μg/kg SHR0410
DRUG	5μg/kg SHR0410	a single dose of 5μg/kg SHR0410
DRUG	10μg/kg SHR0410	a single dose of 10μg/kg SHR0410
DRUG	20μg/kg SHR0410	a single dose of 20μg/kg SHR0410

Timeline

• Start date: 2018-04-15
• Primary completion: 2018-06-29
• Completion: 2018-07-14
• First posted: 2018-04-10
• Last updated: 2019-02-26

Locations

1 site across 1 country: Australia