HealthyPhase 1NCT03685084
Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers
A Phase 1 study testing AAI101 i.v., Saline 0.9% infusion and Piperacillin i.v. in people with Healthy, run by Allecra.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AAI101 i.v., Saline 0.9% infusion and Piperacillin i.v.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2013to 13 Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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
- 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
- Being tested
- AAI101 i.v., Saline 0.9% infusion, Piperacillin i.v., Cefepime i.v.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAI101 i.v.Drug
Also called AAI101
600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)
Saline 0.9% infusionDrug
Also called Vehicle
Vehicle infusion
Piperacillin i.v.Drug
Also called Beta-lactam antibiotic
piperacillin 3 g i.v.
Cefepime i.v.Drug
Also called Beta-lactam antibiotic
cefepime 1 g i.v.
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline infusion | Placebo comparator | Saline 0.9% infusion Receives: Drug: AAI101 i.v.; Drug: 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. Receives: Drug: AAI101 i.v.; Drug: Saline 0.9% infusion |
| Piperacillin i.v. | Experimental | Piperacillin 3 g Receives: Drug: Piperacillin i.v. |
| Cefepime i.v. | Experimental | Cefepime 1 g Receives: Drug: Cefepime i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile - Number of Subjects With at Least one Adverse Event
Safety will be evaluated from reported signs and symptoms and clinical laboratory tests
Measured: Throughout the period that subjects receive study drug up to 5 days following discontinuation of study treatment
Secondary outcomes (4)
AAI101 maximum plasma concentration (Cmax)
Cmax will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin
Measured: Up to 24 hours post-dose
AAI101 Clast
Clast will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin
Measured: Up to 24 hours post-dose
AAI101 AUC(0-t) - AUC(0-8)
AAI101 Urea Under the Curve will be compared before and after administration of AAI101 either alone or in the presence of cefepime or piperacillin
Measured: Up to 24 hours post-dose
AAI101 half life (t1/2)
AAI101 t1/2 plasma pharmacokinetic parameter will be compared for AAI101 alone or in the presence of cefepime or piperacillin
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start10 Oct 2013
- Primary completion13 Jan 2014
- Study completion13 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allecra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685084
- Sponsor's protocol ID
- AT-101
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03685084
- Acronym / sponsor ID
- AT-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AllecraIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 13 Jan 2014 (actual)
- Study completion
- 13 Jan 2014 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline infusion | Placebo comparator | Drug: AAI101 i.v., Drug: Saline 0.9% infusionSaline 0.9% infusion |
| AAI101 i.v. | Experimental | Drug: AAI101 i.v., Drug: Saline 0.9% infusion600 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 | Drug: Piperacillin i.v.Piperacillin 3 g |
| Cefepime i.v. | Experimental | Drug: Cefepime i.v.Cefepime 1 g |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAI101 i.v.Also: AAI101600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h) | Drug | 0.9% saline infusion, AAI101 i.v. |
| Saline 0.9% infusionAlso: VehicleVehicle infusion | Drug | 0.9% saline infusion, AAI101 i.v. |
| Piperacillin i.v.Also: Beta-lactam antibioticpiperacillin 3 g i.v. | Drug | Piperacillin i.v. |
| Cefepime i.v.Also: Beta-lactam antibioticcefepime 1 g i.v. | Drug | Cefepime i.v. |
Primary outcome
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
4 secondary outcomes
AAI101 maximum plasma concentration (Cmax)
Time frame: Up to 24 hours post-dose
AAI101 Clast
Time frame: Up to 24 hours post-dose
AAI101 AUC(0-t) - AUC(0-8)
Time frame: Up to 24 hours post-dose
AAI101 half life (t1/2)
Time frame: Up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AAI101 i.v., Saline 0.9% infusion and Piperacillin i.v. in people with Healthy, run by Allecra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.