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Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects

NCT04312568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-03-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study

Conditions

  • Healthy Subject

Interventions

DRUG

Fadanafil

Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose

DRUG

Placebo

Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Haiyan Li, Doctor · Peking University Third Hospital

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
2018-08-10
Primary Completion
2018-12-07
Completion
2018-12-07

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 NCT04312568 on ClinicalTrials.gov