Renal ImpairmentPhase 1NCT06527677
Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects
A Phase 1 study testing ANT3310 and Meropenem in people with Renal Impairment, run by Antabio at 1 site in Germany.
Trial summary
This is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- 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
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2024to 10 Jul 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- Participant must be 18 to 80 years of age (both inclusive) at the time of signing the informed consent.
- BMI within the range of 18.0 to 36.0 kg/m2 (both inclusive) with a body weight ≥ 50 kg.
- Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Ability to cooperate with the investigator and to comply with the requirements of the trial.
- Sufficient venous access for i.v. infusion and PK samplings.
- For participants with renal function impairment: Individualized eGFR <90 mL/min at screening, estimated according to the individualized CKD-EPI equation and stable renal function.
- For participants with ESRD requiring dialysis: Chronic intermittent hemodialysis for ≥3 months prior to dosing.
- For participants with normal renal function: Individualized eGFR ≥90 mL/min at screening, estimated based on serum creatinine measured within 10 days prior to Day -1 according to the CKD-EPI equation.
Main Exclusion Criteria:
- Febrile illness within 1 week before admission to the study center.
- Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution.
- 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.
- 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.
- 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 (e.g., penicillin, cephalosporin, carbapenem, or monobactam).
- History of Gilbert syndrome.
- History of any severe antibiotic-associated superinfections like Clostridium difficile colitis and/or frequent fungal vaginal infections.
- Therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
- Positive results for HBsAg, anti-HCV, HIV antibodies (anti-HIV 1+2).
- For participants with impaired renal function: Acute renal failure or active renal infections, Clinically significant impaired hepatic function, Severe infection or any clinically significant illness within 4 weeks before dosing, Impairment of any other major organ system other than the kidney except underlying disease, Diagnosed malignancy during the past 5 years except completely resected basal cell cancer of the skin, Any kidney transplant during the last 10 years, any other organ transplant during the past 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics & Safety of ANT3310 Combined With Meropenem Administered as a Single Intravenous Infusion to Adult Subjects With Renal Function Impairment
This is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with matching control participants with normal renal function.
Read the detailed description
The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).
- Conditions
- Renal Impairment
- Being tested
- ANT3310, Meropenem
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT3310Drug
ANT3310 will be administered as a single intravenous infusion over 3 hours at a constant rate.
MeropenemDrug
meropenem will be administered as a single intravenous infusion over 3 hours at a constant rate.
| Study group | Role | What they receive |
|---|---|---|
| ANT3310 and Meropenem | Experimental | Participants with mild, moderate, or severe renal function impairment (Panel A, B, and D) and participants with normal renal function (Panel C and F) will receive 1 single dose of a combination of ANT3310 and meropenem.
Participants with End Stage Renal Disease (Panel E) will receive 2 times a single dose of a combination of ANT3310 and meropenem: one single dose during dialysis-free interval ("off- dialysis") and one single dose on the day of dialysis ("on-dialysis"). The same dose will be given in both periods with a washout interval of at least 7 days between administrations. 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 a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Area under the curve from 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Time from dosing to maximum observed concentration (tmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Area under the curve from time 0 to time of last measurable concentration (AUC0-last) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Area under the curve from time 0 to 48h (AUC0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Percentage of AUC0-inf obtained by extrapolation (AUCext) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Total body clearance (CL) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Non-renal clearance (CLNonR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma and urine.
Measured: From pre-dose to Day 3
Apparent volume of distribution during the terminal phase after administration (Vz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Mean residence time (MRT) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Measured: From pre-dose to Day 3
Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to infinity (Ae0-inf) after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Measured: From pre-dose to Day 3
Renal clearance (CLR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Measured: From pre-dose to Day 3
Fraction of dose recovered in urine (fe) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Measured: From pre-dose to Day 3
Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to 48h (Ae0-48h) after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Measured: From pre-dose to Day 3
Fraction of dose recovered in urine from 0 to 48 hours (fe0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Measured: From pre-dose to Day 3
Renal clearance from 0 to 48 hours (CLR[0-48h]) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Measured: From pre-dose to Day 3
Dialysis clearance (CLD) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem in dialysed subjects
Pharmacokinetic parameter of ANT3310 and Meropenem in dialysate and plasma.
Measured: during dialysis
Secondary outcomes (6)
Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after a single i.v. infusion of a combination of ANT3310 and meropenem.
Percentage of participants experiencing ≥ one treatment-emergent adverse event (TEAE) by seriousness, intensity, and relatedness from baseline to end of study (EoS) or early withdrawal.
Measured: 0 hours to Day 9
Number of participants who discontinue due to a TEAE.
Percentage of participants who discontinue due to a TEAE.
Measured: 0 hours to Day 9
Number of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing.
Percentage of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing.
Measured: 0 hours to Day 9
Number of participants meeting the clinically significant abnormal criteria for vital signs measurements at least once after start of dosing.
Percentage of participants meeting the clinically significant abnormal criteria for vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) measurements at least once after start of dosing.
Measured: 0 hours to Day 9
Number of participants who meet the clinically significant abnormal criteria for ECG (Electrocardiogram) parameters.
Percentage of participants who meet the clinically significant abnormal criteria for ECG parameters.
Measured: Day-1 to Day 9
Number of infusion site reactions to assess local venous tolerability
Measured: From pre-dose on Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start19 Jul 2024
- Primary completion3 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antabio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Center Kiel GmbH
- Responsible party
- Sponsor
- Investigators
- Christian Zwingelstein, PharmD, Study director, Antabio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527677
- Sponsor's protocol ID
- ANT3310-1002
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics & Safety of ANT3310 Combined With Meropenem Administered as a Single Intravenous Infusion to Adult Subjects With Renal Function Impairment
- ClinicalTrials.gov ID
- NCT06527677
- Acronym / sponsor ID
- ANT3310-1002
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AntabioIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Center Kiel GmbH
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 30 Jul 2024 (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, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with matching control participants with normal renal function.
Detailed description
The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).
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 | Experimental | Drug: ANT3310, Drug: MeropenemParticipants with mild, moderate, or severe renal function impairment (Panel A, B, and D) and participants with normal renal function (Panel C and F) will receive 1 single dose of a combination of ANT3310 and meropenem. Participants with End Stage Renal Disease (Panel E) will receive 2 times a single dose of a combination of ANT3310 and meropenem: one single dose during dialysis-free interval ("off- dialysis") and one single dose on the day of dialysis ("on-dialysis"). The same dose will be given in both periods with a washout interval of at least 7 days between administrations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 administered as a single intravenous infusion over 3 hours at a constant rate. | Drug | ANT3310 and Meropenem |
| Meropenemmeropenem will be administered as a single intravenous infusion over 3 hours at a constant rate. | Drug | ANT3310 and Meropenem |
Primary outcome
Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Area under the curve from 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Time from dosing to maximum observed concentration (tmax) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Area under the curve from time 0 to time of last measurable concentration (AUC0-last) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Area under the curve from time 0 to 48h (AUC0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Percentage of AUC0-inf obtained by extrapolation (AUCext) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Total body clearance (CL) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Non-renal clearance (CLNonR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma and urine.
Apparent volume of distribution during the terminal phase after administration (Vz) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Mean residence time (MRT) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma.
Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to infinity (Ae0-inf) after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Renal clearance (CLR) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Fraction of dose recovered in urine (fe) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Amount of ANT3310 and Meropenem that is eliminated in urine from 0 to 48h (Ae0-48h) after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Fraction of dose recovered in urine from 0 to 48 hours (fe0-48h) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Renal clearance from 0 to 48 hours (CLR[0-48h]) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem
Time frame: From pre-dose to Day 3
Pharmacokinetic parameter of ANT3310 and Meropenem in urine.
Dialysis clearance (CLD) of ANT3310 and Meropenem after a single i.v. infusion of the combination ANT3310-Meropenem in dialysed subjects
Time frame: during dialysis
Pharmacokinetic parameter of ANT3310 and Meropenem in dialysate and plasma.
6 secondary outcomes
Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after a single i.v. infusion of a combination of ANT3310 and meropenem.
Time frame: 0 hours to Day 9
Number of participants who discontinue due to a TEAE.
Time frame: 0 hours to Day 9
Number of participants who meet the clinically significant abnormal criteria for safety laboratory tests at least once after start of dosing.
Time frame: 0 hours to Day 9
Number of participants meeting the clinically significant abnormal criteria for vital signs measurements at least once after start of dosing.
Time frame: 0 hours to Day 9
Number of participants who meet the clinically significant abnormal criteria for ECG (Electrocardiogram) parameters.
Time frame: Day-1 to Day 9
Number of infusion site reactions to assess local venous tolerability
Time frame: From pre-dose on Day 1 to Day 3
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 29 Jul 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.
Christian Zwingelstein, PharmD study director
Antabio
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 Renal Impairment, run by Antabio at 1 site in Germany.
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 29 Jul 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 Germany. 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 a single i.v. infusion of the combination ANT3310-Meropenem (time frame: From pre-dose to Day 3). The study lists 18 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 29 Jul 2025.