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Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers

NCT03685084 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-09-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Allecra

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-10
Primary Completion
2014-01-13
Completion
2014-01-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03685084 on ClinicalTrials.gov