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drugset / Trial / NCT05640531

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

NCT05640531 ↗

Phase 1 Completed 36 enrolled Wockhardt
RandomizedSequentialQuadruple-blindOther

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.

Timeline

Start
2011-12-01
Primary completion
2012-02-07
Completion
2012-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject WCK 771 Unknown 600 mg Intravenous
Subject WCK 771 Unknown 800 mg Intravenous
Subject WCK 771 Unknown 1000 mg Intravenous

Indications

No indication recorded.