Healthy VolunteersPhase 1NCT05905913
FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects
A Phase 1 study testing ANT3310 and Meropenem in people with Healthy Volunteers, run by Antabio at 1 site in France.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ANT3310 and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2023to 5 Jan 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Participant capable of giving signed informed consent
- Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants are overtly healthy as determined by a medical evaluation including medical history without clinically relevant pathologies, physical examination, vital signs, ECG assessment, and clinical laboratory result
- eGFR ≥ 90 mL/min and < 160 mL/min for males or < 150 mL/min for females
- Body weight within 50.0 and 100.0 kg and BMI within 18.0 and 30.0 kg/m2
Main Exclusion Criteria:
- History of any clinically-relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, haematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer, cirrhosis, significant acute infection, local infection within 2 weeks of dose administration,
- ECG: any history of clinically-significant ECG abnormalities, an uninterpretable ECG, or any of ECG abnormalities, unless considered not significant by the Investigator
- Abnormalities in clinical chemical, haematological, or coagulation variables considered medically relevant by the Investigator,
- Positive urine drug screen, positive breathalyzer for alcohol
- Positive results in any of the following virology tests: HIV-1 and -2 antibodies, HBsAg, and anti-hepatitis C virus antibody
- Positive SARS-CoV-2 antigen test
- Women who are pregnant or nursing,
- Donation or loss of over 500 mL of blood within sixty days prior to the first study drug administration,
Part C with co-administration of meropenem:
- History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders,
- Known history of clinically-significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics,
- History of Gilbert syndrome,
- History of any severe antibiotic-associated superinfections,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of Intravenous ANT3310 Alone and in Combination With Meropenem in Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- ANT3310, ANT3310-placebo, Meropenem, Meropenem-placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT3310Drug
ANT3310 will be infused over 3 hours
ANT3310-placeboDrug
ANT3310-placebo will be infused over 3 hours
ANT3310Drug
ANT3310 will be infused over 3 hours every 8 hours
ANT3310-placeboDrug
ANT3310-placebo will be infused over 3 hours every 8 hours
ANT3310-placeboDrug
ANT3310-placebo will be infused over 3 hours as a single dose as part of the drug drug interaction study, then every 8 hours as part of the repeat doses study.
ANT3310Drug
ANT3310 will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.
MeropenemDrug
Meropenem will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.
Meropenem-placeboDrug
Meropenem-placebo will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Intravenous Ascending Dose of ANT3310 | Experimental | Not described Receives: Drug: ANT3310 |
| Part A: Single Intravenous Dose of Matching placebo | Placebo comparator | Not described Receives: Drug: ANT3310-placebo |
| Part B: Multiple Intravenous Ascending Doses of ANT3310 | Experimental | Not described Receives: Drug: ANT3310 |
| Part B: Multiple Intravenous Ascending Doses of Matching Placebo | Placebo comparator | Not described Receives: Drug: ANT3310-placebo |
| Part C: ANT3310 + Meropenem | Experimental | Participants will receive a single intravenous dose of ANT3310 or Meropenem in one of the 2 treatment sequences followed by the repeat administrations of ANT3310 + Meropenem. Receives: Drug: ANT3310; Drug: Meropenem |
| Part C: ANT3310 Placebo + Meropenem Placebo | Placebo comparator | Participants will receive a single dose of ANT3310-placebo or Meropenem-placebo in one of the 2 treatment sequences followed by repeat administrations of ANT3310-placebo + Meropenem-placebo Receives: Drug: ANT3310-placebo; Drug: Meropenem-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of Treatment Emergent Adverse Events (TEAE) to evaluate the safety and tolerability profile of single and multiple intravenous ascending doses of ANT3310 alone (Part A and B) and in combination with meropenem (Part C)
Percentage of subjects who experience at least one TEAE, including abnormalities in vital signs, physical examinations, laboratory safety tests and ECG, by seriousness, intensity, and relatedness
Measured: up to 11 days
Secondary outcomes (13)
Part A (SAD): Maximum Plasma Concentration (Cmax) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: 24 hours
Part A (SAD): Area under the concentration time curve (AUC) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: 24 hours
Part A (SAD): Time to maximum plasma concentration (Tmax) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: 24 hours
Part A (SAD): Half-time (t1/2) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: 24 hours
Part B (MAD): Maximum Plasma Concentration (Cmax) of multiple i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: Day 1, Day 7
Part B (MAD): Area under the concentration time curve (AUC) of multiple i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: Day 1, Day 7
Part B (MAD): Time to maximum plasma concentration (Tmax) of multiple i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Measured: Day 1, Day 7
Part C (DDI and combination): Maximum Plasma Concentration (Cmax) of a single i.v. dose of ANT3310 and meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Measured: Day 1, Day 3, Day 5
Part C (DDI and combination): Area under the concentration time curve (AUC) of a single i.v. dose of ANT3310 and meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Measured: Day 1, Day 3, Day 5
Part C (DDI and combination): Time to maximum plasma concentration (Tmax) of a single i.v. dose of ANT3310 and meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Measured: Day 1, Day 3, Day 5
Part C (DDI and combination): Maximum Plasma Concentration (Cmax) of multiple i.v. dose of ANT3310 co-administered with meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Measured: Day 11
Part C (DDI and combination): Area under the concentration time curve (AUC) of multiple i.v. dose of ANT3310 co-administered with meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Measured: Day 11
Part C (DDI and combination): Time to maximum plasma concentration (Tmax) of multiple i.v. dose of ANT3310 co-administered with meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Measured: Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Apr 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antabio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophie Hays, MD, Principal investigator, Biotrial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905913
- Sponsor's protocol ID
- ANT3310-1001
- Status last verified
- Mar 2024
- First submitted
- 19 May 2023
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of Intravenous ANT3310 Alone and in Combination With Meropenem in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05905913
- Acronym / sponsor ID
- ANT3310-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AntabioIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 15 Jun 2023 (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.
The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Intravenous Ascending Dose of ANT3310 | Experimental | Drug: ANT3310 |
| Part A: Single Intravenous Dose of Matching placebo | Placebo comparator | Drug: ANT3310-placebo |
| Part B: Multiple Intravenous Ascending Doses of ANT3310 | Experimental | Drug: ANT3310 |
| Part B: Multiple Intravenous Ascending Doses of Matching Placebo | Placebo comparator | Drug: ANT3310-placebo |
| Part C: ANT3310 + Meropenem | Experimental | Drug: ANT3310, Drug: MeropenemParticipants will receive a single intravenous dose of ANT3310 or Meropenem in one of the 2 treatment sequences followed by the repeat administrations of ANT3310 + Meropenem. |
| Part C: ANT3310 Placebo + Meropenem Placebo | Placebo comparator | Drug: ANT3310-placebo, Drug: Meropenem-placeboParticipants will receive a single dose of ANT3310-placebo or Meropenem-placebo in one of the 2 treatment sequences followed by repeat administrations of ANT3310-placebo + Meropenem-placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| ANT3310ANT3310 will be infused over 3 hours | Drug | Part A: Single Intravenous Ascending Dose of ANT3310 |
| ANT3310-placeboANT3310-placebo will be infused over 3 hours | Drug | Part A: Single Intravenous Dose of Matching placebo |
| ANT3310ANT3310 will be infused over 3 hours every 8 hours | Drug | Part B: Multiple Intravenous Ascending Doses of ANT3310 |
| ANT3310-placeboANT3310-placebo will be infused over 3 hours every 8 hours | Drug | Part B: Multiple Intravenous Ascending Doses of Matching Placebo |
| ANT3310-placeboANT3310-placebo will be infused over 3 hours as a single dose as part of the drug drug interaction study, then every 8 hours as part of the repeat doses study. | Drug | Part C: ANT3310 Placebo + Meropenem Placebo |
| ANT3310ANT3310 will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study. | Drug | Part C: ANT3310 + Meropenem |
| MeropenemMeropenem will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study. | Drug | Part C: ANT3310 + Meropenem |
| Meropenem-placeboMeropenem-placebo will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study. | Drug | Part C: ANT3310 Placebo + Meropenem Placebo |
Primary outcome
Number and severity of Treatment Emergent Adverse Events (TEAE) to evaluate the safety and tolerability profile of single and multiple intravenous ascending doses of ANT3310 alone (Part A and B) and in combination with meropenem (Part C)
Time frame: up to 11 days
Percentage of subjects who experience at least one TEAE, including abnormalities in vital signs, physical examinations, laboratory safety tests and ECG, by seriousness, intensity, and relatedness
13 secondary outcomes
Part A (SAD): Maximum Plasma Concentration (Cmax) of single i.v. ascending doses of ANT3310 alone
Time frame: 24 hours
Part A (SAD): Area under the concentration time curve (AUC) of single i.v. ascending doses of ANT3310 alone
Time frame: 24 hours
Part A (SAD): Time to maximum plasma concentration (Tmax) of single i.v. ascending doses of ANT3310 alone
Time frame: 24 hours
Part A (SAD): Half-time (t1/2) of single i.v. ascending doses of ANT3310 alone
Time frame: 24 hours
Part B (MAD): Maximum Plasma Concentration (Cmax) of multiple i.v. ascending doses of ANT3310 alone
Time frame: Day 1, Day 7
Part B (MAD): Area under the concentration time curve (AUC) of multiple i.v. ascending doses of ANT3310 alone
Time frame: Day 1, Day 7
Part B (MAD): Time to maximum plasma concentration (Tmax) of multiple i.v. ascending doses of ANT3310 alone
Time frame: Day 1, Day 7
Part C (DDI and combination): Maximum Plasma Concentration (Cmax) of a single i.v. dose of ANT3310 and meropenem
Time frame: Day 1, Day 3, Day 5
Part C (DDI and combination): Area under the concentration time curve (AUC) of a single i.v. dose of ANT3310 and meropenem
Time frame: Day 1, Day 3, Day 5
Part C (DDI and combination): Time to maximum plasma concentration (Tmax) of a single i.v. dose of ANT3310 and meropenem
Time frame: Day 1, Day 3, Day 5
Part C (DDI and combination): Maximum Plasma Concentration (Cmax) of multiple i.v. dose of ANT3310 co-administered with meropenem
Time frame: Day 11
Part C (DDI and combination): Area under the concentration time curve (AUC) of multiple i.v. dose of ANT3310 co-administered with meropenem
Time frame: Day 11
Part C (DDI and combination): Time to maximum plasma concentration (Tmax) of multiple i.v. dose of ANT3310 co-administered with meropenem
Time frame: Day 11
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 15 Mar 2024.
- 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.
Sophie Hays, MD principal investigator
Biotrial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANT3310 and Meropenem in people with Healthy Volunteers, run by Antabio at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number and severity of Treatment Emergent Adverse Events (TEAE) to evaluate the safety and tolerability profile of single and multiple intravenous ascending doses of ANT3310 alone (Part A and B) and in combination with meropenem (Part C) (time frame: up to 11 days). 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 15 Mar 2024.