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

Wockhardt

Status and phase

Completed

Phase 1

Conditions

Bioavailability

Treatments

Other: Placebo IV Infusion

Drug: WCK 771 IV Infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT05640531

WCK771/P-I/MD/08

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)