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Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685084
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Allecra

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: AAI101 i.v. Drug: Saline 0.9% infusion Drug: Piperacillin i.v. Drug: Cefepime i.v. Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 10, 2013
Actual Primary Completion Date : January 13, 2014
Actual Study Completion Date : January 13, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Placebo Comparator: 0.9% saline infusion
Saline 0.9% infusion
Drug: AAI101 i.v.
600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)
Other Name: AAI101

Drug: Saline 0.9% infusion
Vehicle infusion
Other Name: Vehicle

Experimental: AAI101 i.v.

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.

Drug: AAI101 i.v.
600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)
Other Name: AAI101

Drug: Saline 0.9% infusion
Vehicle infusion
Other Name: Vehicle

Experimental: Piperacillin i.v.
Piperacillin 3 g
Drug: Piperacillin i.v.
piperacillin 3 g i.v.
Other Name: Beta-lactam antibiotic

Experimental: Cefepime i.v.
Cefepime 1 g
Drug: Cefepime i.v.
cefepime 1 g i.v.
Other Name: Beta-lactam antibiotic




Primary Outcome Measures :
  1. Safety Profile - Number of Subjects With at Least one Adverse Event [ Time Frame: Throughout the period that subjects receive study drug up to 5 days following discontinuation of study treatment ]
    Safety will be evaluated from reported signs and symptoms and clinical laboratory tests


Secondary Outcome Measures :
  1. AAI101 maximum plasma concentration (Cmax) [ Time Frame: Up to 24 hours post-dose ]
    Cmax will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin

  2. AAI101 Clast [ Time Frame: Up to 24 hours post-dose ]
    Clast will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin

  3. AAI101 AUC(0-t) - AUC(0-8) [ Time Frame: Up to 24 hours post-dose ]
    AAI101 Urea Under the Curve will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin

  4. AAI101 half life (t1/2) [ Time Frame: Up to 24 hours post-dose ]
    AAI101 t1/2 plasma pharmacokinetic parameter will be compared for AAI101 alone or in the presence of cefepime or piperacillin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy male subjects
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Allecra
ClinicalTrials.gov Identifier: NCT03685084    
Other Study ID Numbers: AT-101
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Piperacillin
Cefepime
Lactams
beta-Lactams
Enmetazobactam
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action