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OpenTrials
Completed

NCT Number: NCT05640531

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

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.

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Key information

Conditions

Bioavailability

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

WCK 771 IV Infusion

Drug

subjects will receive intravenous infusion of WCK 771

Placebo IV Infusion

Other

subjects will receive matching placebo intravenous infusion

Primary outcomes

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

    Time frame: Day 12

    By monitoring the adverse events reported

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

    Time frame: Day 5

    Measuring Cmax Maximum observed plasma concentration.

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Registry information

Official study title

Phase-I, Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771 in Adult Healthy Human Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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