NCT03685084

Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers

Phase I, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of AAI101 Administered Intravenously Alone or in Combination With Piperacillin or Cefepime to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Allecra · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

* To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 (SAD \& MAD) in healthy male subjects. * To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 in combination with fixed intravenous doses of piperacillin or cefepime in healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AAI101 i.v.	600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)
DRUG	Saline 0.9% infusion	Vehicle infusion
DRUG	Piperacillin i.v.	piperacillin 3 g i.v.
DRUG	Cefepime i.v.	cefepime 1 g i.v.

Timeline

• Start date: 2013-10-10
• Primary completion: 2014-01-13
• Completion: 2014-01-13
• First posted: 2018-09-26
• Last updated: 2018-09-26