Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers

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.