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Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers

NCT02477449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-13

No results posted yet for this study

Summary

Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.

Conditions

  • Healthy

Interventions

DRUG

istaroxime

8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).

DRUG

9% Saline (NS)

infusion for 24 hours

Sponsors & Collaborators

  • CVie Therapeutics Co. Ltd.

    collaborator INDUSTRY

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • China

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 NCT02477449 on ClinicalTrials.gov