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The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

NCT03669562 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-09-13

No results posted yet for this study

Summary

Conducted in Chinese healthy adult volunteers,the study aims to observe the safety, tolerability and pharmacokinetic of single-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.

Conditions

  • Lower Extremity Arterial Occlusive Diseases

Interventions

DRUG

Alprostadil Liposome for Injection

intravenous infusion Alprostadil Liposome

DRUG

Placebo

intravenous infusion liposome control

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2018-10-15
Completion
2018-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03669562 on ClinicalTrials.gov