Pharmacokinetics Study on Healthy Volunteers AdultsPhase 1NCT06916156
Evaluation of the Concentration of ANT3310 and Meropenem in the Lung in Healthy Adult Participants
A Phase 1 study testing ANT3310 and Meropenem in people with Pharmacokinetics Study on Healthy Volunteers Adults, run by Antabio at 1 site in United States.
Trial summary
This is an open-label, non-randomized, single-center, repeated i.v. doses, Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of a combination of MEM-ANT3310 in healthy adult female and male participants who will undergo a single bronchoalveolar lavage (BAL) via a standardized fiberoptic… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics Study on Healthy Volunteers Adults
- What is being tested?
- ANT3310 and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 19 Aug 2025
- 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
Who may be able to join
- Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Participants must be 18 to 55 years of age, both inclusive, at the time of signing the informed consent.
- Body mass index (BMI) within the range 18.0-32.0 kg/m2 (both inclusive) and body weight > 50.0 kg (110 Ibs) at Screening.
- Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Healthy participants as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, 12-lead ECG, vital signs, physical examination, spirometry at Screening (FEV1 > 80% of predicted), and clinical laboratory tests at Screening and Day -1.
- Healthy participants with vital signs at Screening and Day -1 within the normal ranges: tympanic body temperature: ≥ 35.5°C and ≤ 37.5°C; resting pulse rate ≥ 50 beats per minute (bpm) and ≤ 100 bpm; systolic blood pressure (SBP) ≥ 90 and ≤ 139 mmHg, diastolic blood pressure (DBP) ≥ 50 and ≤ 89 mmHg, taken in supine position after resting at least 5 minutes. On Day -1, blood pressure and pulse rate need to be within the normal ranges or not clinically significant range, as per investigator's judgement.
- Individualized estimated glomerular filtration rate (eGFR): [(CKD-EPI ÷ 1.73) × BSA] ≥ 90 mL/min and < 160 mL/min for males or < 150 mL/min for females at Screening.
- Sufficient venous access for i.v. infusion and PK samplings.
Who cannot join
- History of any clinically relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, hematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer (may have had basal or squamous cell carcinoma of skin or cervix so long as surgically removed or deemed cured by cryotherapy, laser therapy, conization, etc, with stability for the past two years).
- History or presence of chronic pulmonary disease.
- Medical disorder, condition, or history of such that would - in the opinion of the Investigator - compromise the participant's ability to participate in this study.
- Presence of any acute illness, including febrile illness with temperature > 37.8°C (> 100.0°F), within 7 days of Baseline (Day -1 to Day 1).
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
- Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution.
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- Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics (i.e., penicillin, cephalosporin, carbapenem, or monobactam).
- History of significant bleeding within the past 3 months.
- History of COVID-19 within three (3) months prior to Screening.
- History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders.
- History of Gilbert syndrome.
- History of any severe antibiotic-associated superinfections, such as Clostridium difficile colitis and/or frequent fungal vaginal infections.
- Contraindications to bronchoalveolar lavage or suspected intolerability to medications necessary for bronchoscopy, hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the last 6 months, heart failure, and severe hemostatic alterations. Anatomical or anticipated technical difficulties that would prevent bronchoscopy or BAL procedure. Allergies to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single Center Study to Determine the Penetration of ANT3310 and Meropenem Into the Lung After Repeated Intravenous Administrations of MEM-ANT3310 in Healthy Adult Participants
This is an open-label, non-randomized, single-center, repeated i.v. doses, Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of a combination of MEM-ANT3310 in healthy adult female and male participants who will undergo a single bronchoalveolar lavage (BAL) via a standardized fiberoptic bronchoscopy to evaluate and compare the pharmacokinetics characteristics of ANT3310 and meropenem (MEM) in plasma and epithelial lining luid (ELF).
Read the detailed description
There will be 25 participants enrolled in the study. Each participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours. Each participant will undergo a single bronchoscopy at the assigned BAL sampling time. Blood samples will be collected. Participants will be monitored for adverse events from study center admittance through the EoS visit.
- Being tested
- ANT3310, Meropenem
- Keywords
- healthy volunteers, Bronchoalveolar lavage (BAL) study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT3310Drug
ANT3310 will be administered in combination with Meropenem. Participants will receive 3 intravenous infusions of the combination MEM-ANT3310 every 8 hours. Infusions will be delivered through an infusion line over 3 hours at a constant rate.
MeropenemDrug
Meropenem will be administered in combination with ANT3310. Participants will receive 3 intravenous infusions of the combination MEM-ANT3310 every 8 hours. Infusions will be delivered through an infusion line over 3 hours at a constant rate.
| Study group | Role | What they receive |
|---|---|---|
| ANT3310 and Meropenem (MEM) | Experimental | Each participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours (i.e., 0 hour, 8 hours, and 16 hours relative to start of the first infusion). Receives: Drug: ANT3310; Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Area under the concentration-time curve from 0 to 8 hours post-dose (AUC0-8h) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Percent penetration of ANT3310 and Meropenem in epithelial lining fluid (ELF) after repeated i.v. infusions of a combination of ANT3310 and Meropenem
ratio (%) of AUC0-8h of ELF-to-plasma for ANT3310 and Meropenem
Measured: From pre-dose to 8 hours post-last-dose
Time from dosing to maximum observed plasma concentration (tmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem in plasma after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Terminal phase elimination rate constant (λz) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Apparent total body clearance at steady-state (CLss) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Apparent volume of distribution at steady-state (Vss) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Measured: From pre-dose to 8 hours post-last-dose
Apparent elimination half-life (t1/2,ELF) of ANT3310 and Meropenem in ELF after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in ELF
Measured: From pre-dose to 8 hours post-last-dose
Secondary outcomes (6)
Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Percentage of participants experiencing ≥ one TEAE by seriousness, intensity, and relatedness from baseline through end of study visit
Measured: From Day 1 to Day 11
Number of participants who discontinue due to a TEAE.
Percentage of participants who discontinue due to a TEAE.
Measured: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for safety laboratory tests at least once post-dose
Percentage of participants with clinically significant abnormal values for safety laboratory tests at least once post-dose
Measured: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose
Percentage of participants with clinically significant abnormal values for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose
Measured: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for safety electrocardiogram (ECG) parameters at least once post-dose
Percentage of participants with clinically significant abnormal values for safety electrocardiogram (ECG) parameters at least once post-dose
Measured: From Day 1 to Day 11
Number of infusion site reactions to assess local venous tolerability
Measured: From Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start28 Apr 2025
- Primary completion14 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics Study on Healthy Volunteers AdultsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antabio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Responsible party
- Sponsor
- Investigators
- J. Burr Ross, MD, Principal investigator, Pulmonary Associates, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916156
- Sponsor's protocol ID
- ANT3310-1003
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Center Study to Determine the Penetration of ANT3310 and Meropenem Into the Lung After Repeated Intravenous Administrations of MEM-ANT3310 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06916156
- Acronym / sponsor ID
- ANT3310-1003
- Keywords
- healthy volunteers, Bronchoalveolar lavage (BAL) study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AntabioIndustry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 8 Apr 2025 (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.
This is an open-label, non-randomized, single-center, repeated i.v. doses, Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of a combination of MEM-ANT3310 in healthy adult female and male participants who will undergo a single bronchoalveolar lavage (BAL) via a standardized fiberoptic bronchoscopy to evaluate and compare the pharmacokinetics characteristics of ANT3310 and meropenem (MEM) in plasma and epithelial lining luid (ELF).
Detailed description
There will be 25 participants enrolled in the study. Each participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours. Each participant will undergo a single bronchoscopy at the assigned BAL sampling time. Blood samples will be collected. Participants will be monitored for adverse events from study center admittance through the EoS visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANT3310 and Meropenem (MEM) | Experimental | Drug: ANT3310, Drug: MeropenemEach participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours (i.e., 0 hour, 8 hours, and 16 hours relative to start of the first infusion). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Participants must be 18 to 55 years of age, both inclusive, at the time of signing the informed consent.
- Body mass index (BMI) within the range 18.0-32.0 kg/m2 (both inclusive) and body weight > 50.0 kg (110 Ibs) at Screening.
- Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Healthy participants as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, 12-lead ECG, vital signs, physical examination, spirometry at Screening (FEV1 > 80% of predicted), and clinical laboratory tests at Screening and Day -1.
Key exclusion criteria (13 listed)
- History of any clinically relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, hematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer (may have had basal or squamous cell carcinoma of skin or cervix so long as surgically removed or deemed cured by cryotherapy, laser therapy, conization, etc, with stability for the past two years).
- History or presence of chronic pulmonary disease.
- Medical disorder, condition, or history of such that would - in the opinion of the Investigator - compromise the participant's ability to participate in this study.
- Presence of any acute illness, including febrile illness with temperature > 37.8°C (> 100.0°F), within 7 days of Baseline (Day -1 to Day 1).
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
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 administered in combination with Meropenem. Participants will receive 3 intravenous infusions of the combination MEM-ANT3310 every 8 hours. Infusions will be delivered through an infusion line over 3 hours at a constant rate. | Drug | ANT3310 and Meropenem (MEM) |
| MeropenemMeropenem will be administered in combination with ANT3310. Participants will receive 3 intravenous infusions of the combination MEM-ANT3310 every 8 hours. Infusions will be delivered through an infusion line over 3 hours at a constant rate. | Drug | ANT3310 and Meropenem (MEM) |
Primary outcome
Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Area under the concentration-time curve from 0 to 8 hours post-dose (AUC0-8h) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Percent penetration of ANT3310 and Meropenem in epithelial lining fluid (ELF) after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
ratio (%) of AUC0-8h of ELF-to-plasma for ANT3310 and Meropenem
Time from dosing to maximum observed plasma concentration (tmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem in plasma after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Terminal phase elimination rate constant (λz) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Apparent total body clearance at steady-state (CLss) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Apparent volume of distribution at steady-state (Vss) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Apparent elimination half-life (t1/2,ELF) of ANT3310 and Meropenem in ELF after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Pharmacokinetic parameter of ANT3310 and Meropenem in ELF
6 secondary outcomes
Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Time frame: From Day 1 to Day 11
Number of participants who discontinue due to a TEAE.
Time frame: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for safety laboratory tests at least once post-dose
Time frame: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose
Time frame: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for safety electrocardiogram (ECG) parameters at least once post-dose
Time frame: From Day 1 to Day 11
Number of infusion site reactions to assess local venous tolerability
Time frame: From Day 1 to 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 2 Oct 2025.
- 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.
J. Burr Ross, MD principal investigator
Pulmonary Associates, PA
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 Pharmacokinetics Study on Healthy Volunteers Adults, run by Antabio at 1 site in United States.
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 13 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 2 Oct 2025. 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 United States. 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. 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?
Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem (time frame: From pre-dose to 8 hours post-last-dose). The study lists 10 primary outcomes in all. 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 2 Oct 2025.