NCT05640531

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	WCK 771 IV Infusion	subjects will receive intravenous infusion of WCK 771
OTHER	Placebo IV Infusion	subjects will receive matching placebo intravenous infusion

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-02-07
• Completion: 2012-06-27
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study