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Completed
NCT05640531
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771
Conditions: Bioavailability
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 36
Sponsor: Wockhardt
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg/height in m2Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordingsExclusion Criteria:Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugsAny 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 systemUse 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)
Source: ClinicalTrials.gov (NCT05640531). StuddyBuddy aggregates publicly available trial information.