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A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers

NCT02750553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-04-26

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, single \& multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 5 mg followed by dose escalation groups up to 100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug or placebo.

Conditions

  • Healthy

Interventions

DRUG

SHR0534

DRUG

Placebo

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31

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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 NCT02750553 on ClinicalTrials.gov