Trial | NCT03685084  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
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
Study Started
Oct 10
2013
Primary Completion
Jan 13
2014
Study Completion
Jan 13
2014
Last Update
Sep 26
2018

Drug AAI101 i.v.

600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)

  • Other names: AAI101

Drug Saline 0.9% infusion

Vehicle infusion

  • Other names: Vehicle

Drug Piperacillin i.v.

piperacillin 3 g i.v.

  • Other names: Beta-lactam antibiotic

Drug Cefepime i.v.

cefepime 1 g i.v.

  • Other names: Beta-lactam antibiotic

0.9% saline infusion Placebo Comparator

Saline 0.9% infusion

AAI101 i.v. Experimental

600 mg, 1g, 2g, 4g, 1g q6h, 2g q6h. Drug-Drug Interaction: Sequence 1 = piperacillin 4 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v. - cefepime 2 g i.v. - AAI101 2 g + cefepime 2 g i.v. Sequence 2 = cefepime 2 g i.v. - piperacillin 4 g i.v. - AAI101 2 g + cefepime 2 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v.

Piperacillin i.v. Experimental

Piperacillin 3 g

Cefepime i.v. Experimental

Cefepime 1 g

Criteria 

Inclusion Criteria:

Male healthy volunteers aged between 18 and 45 years (inclusive) at screening.
Body mass index (BMI) of 18.0 to 30.0 Kg/m2 (inclusive) at screening.
Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings (all results were to be within normal range or considered non-clinically significant by the investigator).
Non-smoker or smoker of fewer than 10 cigarettes per day as determined by medical history. Had to be able to abstain from smoking during the inpatient stay.
Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Main Exclusion Criteria:

Any significant cardiovascular (e.g., hypertension), hepatic, renal, respiratory (e.g., childhood asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia), immunologic, hematological, neurologic, or psychiatric disease.
Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days before study Day 1.
No Results Posted