MedTrace Logo

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771

NCT05640531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-12-07

No results posted yet for this study

Summary

The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.

Conditions

  • Bioavailability

Interventions

DRUG

WCK 771 IV Infusion

subjects will receive intravenous infusion of WCK 771

OTHER

Placebo IV Infusion

subjects will receive matching placebo intravenous infusion

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Ashima Bhatia, MD · Wockhardt Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2012-02-07
Completion
2012-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05640531 on ClinicalTrials.gov