NCT01015014

Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

First-in-human, Two-stage, Randomized, Placebo-controlled, Double-blind, Dose Escalation Study To Determine The Safety, Tolerability, And Pharmacokinetic Profile Of An3365 In Single And Multiple Doses In Young Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.

Detailed description

Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.

Conditions

• Gram-negative Bacterial Infection

Interventions

Type	Name	Description
DRUG	AN3365	LP, 600 mg vial; reconstituted in Normal Saline
DRUG	Placebo	0.9% sodium chloride for injection

Timeline

• Start date: 2009-11-05
• Primary completion: 2010-05-13
• Completion: 2010-05-13
• First posted: 2009-11-17
• Last updated: 2019-03-05

Locations

1 site across 1 country: Australia