Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers

A

Allecra

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Saline 0.9% infusion
Drug: Piperacillin i.v.
Drug: Cefepime i.v.
Drug: AAI101 i.v.

Study type

Interventional

Funder types

Industry

Identifiers

NCT03685084
AT-101

Details and patient eligibility

About

* 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

Enrollment

56 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

56 participants in 4 patient groups, including a placebo group

0.9% saline infusion
Placebo Comparator group
Description:
Saline 0.9% infusion
Treatment:
Drug: AAI101 i.v.
Drug: Saline 0.9% infusion
AAI101 i.v.
Experimental group
Description:
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.
Treatment:
Drug: AAI101 i.v.
Drug: Saline 0.9% infusion
Piperacillin i.v.
Experimental group
Description:
Piperacillin 3 g
Treatment:
Drug: Piperacillin i.v.
Cefepime i.v.
Experimental group
Description:
Cefepime 1 g
Treatment:
Drug: Cefepime i.v.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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