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

Phase 1

Completed

• Conditions: Bioavailability
• Interventions: Drug: WCK 771 IV Infusion; Other: Placebo IV Infusion

• Registration Number: NCT05640531
• Lead Sponsor: Wockhardt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-01
• Primary Completion: 2012-02-07
• Study Completion: 2012-06-27
• Study First Submitted: 2021-04-30
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
WCK 771	WCK 771 IV Infusion	WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion
Placebo infusion	Placebo IV Infusion	Matching Placebo administered as IV infusion

Primary Outcome Measures

Name	Time	Method
To evaluate the safety & tolerability of multiple doses of WCK 771	Day 12	By monitoring the adverse events reported
To evaluate the pharmacokinetics of multiple doses of WCK 771	Day 5	Measuring Cmax Maximum observed plasma concentration.

Trial Locations

Locations (1)

PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200; 🇺🇸 Austin, Texas, United States