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A Single Dose Study of SHR0410 in Healthy Male Participants

NCT03493191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Acute Pain

Interventions

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

Sponsors & Collaborators

  • Linear Clinical Research

    collaborator INDUSTRY

  • Atridia Pty Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2018-06-29
Completion
2018-07-14

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493191 on ClinicalTrials.gov