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CompletedNCT05640531Updated Dec 7, 2022

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

A Phase 1 interventional study of WCK 771 IV Infusion and Placebo IV Infusion in Bioavailability, sponsored by Wockhardt. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Wockhardt · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Feb 2012, 14 years 8 months ago, and no results have been posted to the registry.
  • Registered 9 years 4 months after the study started (first participant enrolled Dec 2011, registered Apr 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Bioavailability
03

In context

Lead sponsor

Wockhardt is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg/height in m2
  • Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs
  • Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
  • Use of any prescription drug within 14 days prior to start of the study (check-in) and nonprescription drug within 7 days prior to start of study (check-in)
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    WCK 771

    WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion

    Drug: WCK 771 IV Infusion

  • Placebo comparator
    Placebo infusion

    Matching Placebo administered as IV infusion

    Other: Placebo IV Infusion

Interventions

  • DrugWCK 771 IV Infusion

    subjects will receive intravenous infusion of WCK 771

  • OtherPlacebo IV Infusion

    subjects will receive matching placebo intravenous infusion

06

What researchers measure

Primary outcomes

  1. To evaluate the safety & tolerability of multiple doses of WCK 771

    By monitoring the adverse events reported

    Time frame: Day 12

  2. To evaluate the pharmacokinetics of multiple doses of WCK 771

    Measuring Cmax Maximum observed plasma concentration.

    Time frame: Day 5

07

Study locations

1 site
  • PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200
    Austin, Texas 78744, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05640531
Lead sponsor
Wockhardt
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Dec 1, 2011
Primary completion
Feb 7, 2012
Completion
Jun 27, 2012
Last update
Dec 7, 2022

Study contacts

Ashima Bhatia, MD
study director · Wockhardt Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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