Healthy SubjectsPhase 1NCT06360640
A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults
A Phase 1 study of Healthy Subjects, run by AdjuTec Pharma AS at 1 site in Sweden.
Trial summary
The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSweden
- Study dates
- 2 Sep 2024to 10 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written informed consent for participation in the trial.
- Healthy females of non-childbearing potential and healthy males aged ≥18 and ≤60 years at the time of the screening visit.
- BMI ≥ 18.5 and ≤ 30.0 at the time of the screening visit, and body weight of ≥50 and ≤100 kg.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
- Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse and refrain from donating sperm from the administration of investigational medicinal product (IMP) until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use a highly effective method of contraception with a failure rate of <1 % to prevent pregnancy from at least 2 weeks prior to the administration of IMP to 3 months after the administration of IMP.
- Women of non-childbearing potential.
- Adequate renal function at the screening visit: Creatinine estimated glomerular filtration rate (eGFR) ≥80 mL/min/1.73 m2 for participants aged 18-50 years and eGFR ≥60 mL/min/1.73 m2 for participants ≥51 years and S-creatinine ≤ upper limit of normal.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- History of kidney disease or renal stone.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges:
Show all 27Show fewer
- Systolic blood pressure: <90 or ≥140 mmHg, or
- Diastolic blood pressure <50 or ≥90 mmHg, or
- Pulse <40 or >90 bpm
- A mean QTcF (QT corrected for heart rate by Fredericia's formula) interval of >450 ms after triplicate measurements. The average of the 3 QTc(F) values will be used to determine the participant's eligibility.
- 12-lead ECG:
- with PR interval shortening < 120 ms.
- PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre- excitation OR
- PR interval prolongation > 220 ms OR
- Intermittent second or third degree atrioventricular (AV) block, or AV dissociation
- History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to APC148.
- Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, vitamins and minerals, within 2 weeks prior to the administration of IMP, except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B/C antibodies and/or HIV.
- Positive result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the administration of the IMP.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous Phase I trials are not to be excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week is allowed before the screening visit.
- History of, or current, drug abuse, use of anabolic steroids, alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Excessive caffeine consumption defined by a daily intake of > 5 cups (1 cup = approximately 240 mL) of caffeine containing beverages, as judged by the Investigator.
- Plasma donation within 1 month of the IMP infusion or blood donation (or corresponding blood loss) during the last 3 months prior to the IMP infusion.
- Participated in a previous cohort in the trial.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults
The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults.
Read the detailed description
Participants will receive a single 3-hours IV infusion of APC148 or placebo. 6 sequential cohorts are planned. The first 2 subjects in each cohort will be dosed in a sentinel fashion. The subjects will be followed for 7 days.
- Conditions
- Healthy Subjects
- Being tested
- APC148 and Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APC148 and PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 50 mg of APC148 and placebo | Experimental | Cohort 1: 4 participants receives 3 hours IV administration of 50 mg APC148, and 2 participants placebo. Receives: Drug: APC148 and Placebo |
| 150 mg of APC148 and placebo | Experimental | Cohort 2: 6 participants receives 3 hours IV administration of 150 mg APC148 and 2 participants placebo. Receives: Drug: APC148 and Placebo |
| 300 mg of APC148 and placebo | Experimental | Cohort 3: 6 participants receives 3 hours IV administration of 300 mg APC148 and 2 participants placebo. Receives: Drug: APC148 and Placebo |
| 450 mg of APC148 and placebo | Experimental | Cohort 4: 6 participants receives 3 hours IV administration of 450 mg APC148 and 2 participants placebo. Receives: Drug: APC148 and Placebo |
| 600 mg of APC148 and placebo | Experimental | Cohort 5: 6 participants receives 3 hours IV administration of 600 mg APC148 and 2 participants placebo. Receives: Drug: APC148 and Placebo |
| 900 mg of APC148 and placebo | Experimental | Cohort 6: 6 participants receives 3 hours IV administration of 900 mg APC148 and 2 participants placebo. Receives: Drug: APC148 and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and intensity of adverse events (AEs)
Frequency, intensity and seriousness of adverse events (AEs) will be assessed. The intensity grades is defined as mild, moderate or severe. AEs will be assessed as not related, possibly or probably related to the investigational medicinal product (IMP)
Measured: From start of infusion until end of trial visit Day 8
Incidence and intensity of serious adverse events (SAEs)
Frequency, intensity and seriousness of Serious adverse events (SAEs) will be assessed. Assessment of causal relationship to IMP will be assessed.
Measured: From start of infusion until end of trial visit Day 8
Incidence and intensity of infusion-related AEs
Frequency, intensity and seriousness of infusion-related adverse events (AEs) will be assessed. The intensity grades is defined as mild, moderate or severe. AEs will be assessed as not related, possibly or probably related to the investigational medicinal product (IMP)
Measured: From start of infusion until end of trial visit Day 8
Time course of local tolerability reactions
The infusion site area will be visually inspected before, during and after the IMP infusion. The assessment will include the Investigator's evaluation of swelling, haematoma, and erythema. In addition, each participant will assess their subjective experience of pain and pruritus. Local tolerability reactions will be recorded as infusion-related Adverse events (AEs)
Measured: Pre-dose, Day 1, Day 2 and Day 8
Changes from baseline in blood pressure
Systolic and diastolic blood pressure and pulse will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in respiratory rate
Respiratory rate will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in body temperature
Body temperature will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day1, Day 2, Day 3 and Day 8
Changes from baseline in heart rate
Heart rate will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in PQ/PR interval
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. PQ/PR intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in QRS interval
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. QRS intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in QT interval
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. QT intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in QTcF interval
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. QTcF intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in Clinical Laboratory Profile
Safety laboratory data, Clinical chemistry, haematology, and coagulation, will be measured. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Measured: Day -1, Day 1, Day 2, Day 3 and Day 8
Changes from baseline in physical examination
Assessment of different organ systems. Clinically significant and non-clinically significant abnormal findings will be summarised by treatment and dose.
Measured: Day -1, Day 1, Day 3 and Day 8
Secondary outcomes (14)
APC148 plasma concentrations
Concentration of APC148 in plasma. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2 and Day 3
APC148 urine concentrations
Concentration of APC148 in urine. Urine samples for the determination of plasma concentrations will be collected.
Measured: Day 1 and Day 2
Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24
Area under the plasma concentration vs. time curve from time 0 to 24 hours. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - AUC0-inf
AUC from time 0 to infinity. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - AUC0-last
AUC from time 0 to the last measurable concentration. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - Cmax
Maximum observed plasma concentration. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - Tmax
Time to Cmax. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - T1/2
Terminal elimination half-life. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - Clearance (CL)
Total clearance. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - Vz
Volume of distribution. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameter in plasma - Vss determination of plasma concentrations will be collected.
Apparent volume of distribution at equilibrium. Venous blood samples (approximately 4 mL) for the determination of plasma concentrations will be collected.
Measured: Day 1, Day 2, Day 3
PK parameters in urine - A(e)
Urine samples for the amount of unchanged drug excreted into urine (Ae) will be collected.
Measured: Day 1 and Day 2
PK parameters in urine - fe
Urine samples for the Fraction of IV administered drug that is excreted into urine will be collected.
Measured: Day 1 and Day 2
PK parameter in urine - renal clearance (CLr)
Urine samples for Renal clearance will be collected.
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start2 Sep 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Placebo-controlled, 6 sequential cohorts.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdjuTec Pharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Erik Rein-Hedin, MD, Principal investigator, Clinical Trial Consultants AB (CTC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360640
- Sponsor's protocol ID
- APC148-001
- Other IDs
- 2023-507939-38-00, 2023
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolstad B, Hovland R, Bylund J, Rein-Hedin E, Kuusk S, Klem B, Rongved P. Phase I dose-ascending, safety, and pharmacokinetics study of APC148, a novel metallo-beta-lactamase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0042626. doi: 10.1128/aac.00426-26. Epub 2026 Jun 17.
PubMed 42307233
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06360640
- Acronym / sponsor ID
- APC148-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AdjuTec Pharma ASIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 11 Apr 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.
The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults.
Detailed description
Participants will receive a single 3-hours IV infusion of APC148 or placebo. 6 sequential cohorts are planned. The first 2 subjects in each cohort will be dosed in a sentinel fashion. The subjects will be followed for 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Placebo-controlled, 6 sequential cohorts.
| Arm | Type | Receives |
|---|---|---|
| 50 mg of APC148 and placebo | Experimental | Drug: APC148 and PlaceboCohort 1: 4 participants receives 3 hours IV administration of 50 mg APC148, and 2 participants placebo. |
| 150 mg of APC148 and placebo | Experimental | Drug: APC148 and PlaceboCohort 2: 6 participants receives 3 hours IV administration of 150 mg APC148 and 2 participants placebo. |
| 300 mg of APC148 and placebo | Experimental | Drug: APC148 and PlaceboCohort 3: 6 participants receives 3 hours IV administration of 300 mg APC148 and 2 participants placebo. |
| 450 mg of APC148 and placebo | Experimental | Drug: APC148 and PlaceboCohort 4: 6 participants receives 3 hours IV administration of 450 mg APC148 and 2 participants placebo. |
| 600 mg of APC148 and placebo | Experimental | Drug: APC148 and PlaceboCohort 5: 6 participants receives 3 hours IV administration of 600 mg APC148 and 2 participants placebo. |
| 900 mg of APC148 and placebo | Experimental | Drug: APC148 and PlaceboCohort 6: 6 participants receives 3 hours IV administration of 900 mg APC148 and 2 participants placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent for participation in the trial.
- Healthy females of non-childbearing potential and healthy males aged ≥18 and ≤60 years at the time of the screening visit.
- BMI ≥ 18.5 and ≤ 30.0 at the time of the screening visit, and body weight of ≥50 and ≤100 kg.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
- Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse and refrain from donating sperm from the administration of investigational medicinal product (IMP) until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use a highly effective method of contraception with a failure rate of <1 % to prevent pregnancy from at least 2 weeks prior to the administration of IMP to 3 months after the administration of IMP.
Key exclusion criteria (27 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- History of kidney disease or renal stone.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
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 |
|---|---|---|
| APC148 and PlaceboIV infusion | Drug | 150 mg of APC148 and placebo, 300 mg of APC148 and placebo, 450 mg of APC148 and placebo, 50 mg of APC148 and placebo, 600 mg of APC148 and placebo, 900 mg of APC148 and placebo |
Primary outcome
Incidence and intensity of adverse events (AEs)
Time frame: From start of infusion until end of trial visit Day 8
Frequency, intensity and seriousness of adverse events (AEs) will be assessed. The intensity grades is defined as mild, moderate or severe. AEs will be assessed as not related, possibly or probably related to the investigational medicinal product (IMP)
Incidence and intensity of serious adverse events (SAEs)
Time frame: From start of infusion until end of trial visit Day 8
Frequency, intensity and seriousness of Serious adverse events (SAEs) will be assessed. Assessment of causal relationship to IMP will be assessed.
Incidence and intensity of infusion-related AEs
Time frame: From start of infusion until end of trial visit Day 8
Frequency, intensity and seriousness of infusion-related adverse events (AEs) will be assessed. The intensity grades is defined as mild, moderate or severe. AEs will be assessed as not related, possibly or probably related to the investigational medicinal product (IMP)
Time course of local tolerability reactions
Time frame: Pre-dose, Day 1, Day 2 and Day 8
The infusion site area will be visually inspected before, during and after the IMP infusion. The assessment will include the Investigator's evaluation of swelling, haematoma, and erythema. In addition, each participant will assess their subjective experience of pain and pruritus. Local tolerability reactions will be recorded as infusion-related Adverse events (AEs)
Changes from baseline in blood pressure
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Systolic and diastolic blood pressure and pulse will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in respiratory rate
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Respiratory rate will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in body temperature
Time frame: Day1, Day 2, Day 3 and Day 8
Body temperature will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in heart rate
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Heart rate will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in PQ/PR interval
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. PQ/PR intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in QRS interval
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. QRS intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in QT interval
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. QT intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in QTcF interval
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. QTcF intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in Clinical Laboratory Profile
Time frame: Day -1, Day 1, Day 2, Day 3 and Day 8
Safety laboratory data, Clinical chemistry, haematology, and coagulation, will be measured. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator.
Changes from baseline in physical examination
Time frame: Day -1, Day 1, Day 3 and Day 8
Assessment of different organ systems. Clinically significant and non-clinically significant abnormal findings will be summarised by treatment and dose.
14 secondary outcomes
APC148 plasma concentrations
Time frame: Day 1, Day 2 and Day 3
APC148 urine concentrations
Time frame: Day 1 and Day 2
Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - AUC0-inf
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - AUC0-last
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - Cmax
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - Tmax
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - T1/2
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - Clearance (CL)
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - Vz
Time frame: Day 1, Day 2, Day 3
PK parameter in plasma - Vss determination of plasma concentrations will be collected.
Time frame: Day 1, Day 2, Day 3
PK parameters in urine - A(e)
Time frame: Day 1 and Day 2
PK parameters in urine - fe
Time frame: Day 1 and Day 2
PK parameter in urine - renal clearance (CLr)
Time frame: Day 1 and Day 2
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 12 Mar 2025.
- Derived from this study: PubMed 42307233Bolstad B, Hovland R, Bylund J, Rein-Hedin E, Kuusk S, Klem B, Rongved P. Phase I dose-ascending, safety, and pharmacokinetics study of APC148, a novel metallo-beta-lactamase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0042626. doi: 10.1128/aac.00426-26. Epub 2026 Jun 17.
- 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.
Erik Rein-Hedin, MD principal investigator
Clinical Trial Consultants AB (CTC)
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 of Healthy Subjects, run by AdjuTec Pharma AS at 1 site in Sweden.
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 7 inclusion and 27 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 12 Mar 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 Sweden. 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?
Incidence and intensity of adverse events (AEs) (time frame: From start of infusion until end of trial visit Day 8). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360640, which also lists 1 linked publication.
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 12 Mar 2025.