Bacterial InfectionsPhase 1NCT04802863

Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects

A Phase 1 study testing XNW4107, Imipenem/Cilastatin in people with Bacterial Infections, run by Evopoint Biosciences Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Bacterial Infections
What is being tested?: XNW4107, Imipenem/Cilastatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 25 Mar 2021to 30 Sep 2021
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

1． Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening;
2. BMI ≥ 18.5 and ≤ 32 (kg/m²) and weight between 55.0 and 100.0 kg (both inclusive);
3. Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry, coagulation and urinalysis;
4. Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening;
5. Non-smoker (with no use of other tobacco, nicotine or marijuana-containing products, in any form), as documented by history (no nicotine or marijuana use within 3 months prior to Screening);
6. Negative urine drug, alcohol or cotinine testing at screening and check-in (Day -1);
7. Participants of reproductive potential (male or female) must be willing to use contraception
8. Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or product containing any of these from 72 hours prior to study drug administration until discharge from the clinical unit.

Who cannot join

1. History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant;
2. Recent history (within 6 months) of known or suspected Clostridium difficile infection;
3. History of seizure disorder;
4. Positive testing for human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab);
5. Positive RT-PCR testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
6. Close contact with anyone who tested positive for SARS-CoV-2 infection, or presence of symptoms associated with SARS-CoV-2 infection at Screening or Check-in, or within 14 days prior to Screening.

Show all 15Show fewer

7. Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females obtained after at least 5 min in a supine or semi-supine position at quiet rest at Screening or Check-In (Day -1);
8. Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including: a. White blood cell count < 3,000/mm³, hemoglobin < 11g/dL; b. Absolute neutrophil count <1,200/mm³, platelet count <120,000/mm³; c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory;
9. History of substance abuse or alcohol abuse within the previous 5 years;
10. Use of prescription medications (with the exception of hormone replacement therapy and contraceptives listed in inclusion criterion #10), including nonsteroidal anti-inflammatory drugs, sucralfate, or herbal preparations within 7 days before Check in (Day -1), or use of an over-the-counter medication, acetaminophen (>2 g/day), vitamins, or supplements (including fish liver oils) within 7 days before Check in (Day -1); or probenecid or valproic acid within 30 days before Check in (Day -1);
11. History of hypersensitivity to β-lactam antibiotics or drugs that include sulfobutylether β-cyclodextrin sodium (SBECD) as an excipient (e.g. Tegretol, Vfend, Geodon and Noxafil);
12. History of significant multiple and/or severe allergies (including latex allergy); anaphylactic reaction; or significant prescription drug, non-prescription drug, or food intolerance.
13. Donation of blood or plasma within 30 days prior to Check-In (Day-1), or loss of whole blood of more than 500 mL within 30 days prior to Check-In (Day-1), or receipt of a blood transfusion within 1 year of study enrollment;
14. Participation in another investigational clinical trial within 30 days prior to screening;
15. A female who is pregnant or breastfeeding;

Trial locations and contacts

1 site in 1 country.

United States1 site

Pulmonary Associates PA
Phoenix, Arizona, 85032

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects

This is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously.

Conditions: Bacterial Infections
Being tested: XNW4107, Imipenem/Cilastatin
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XNW4107, Imipenem/CilastatinDrug
Five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin

Study groups in NCT04802863
Study group	Role	What they receive
Five doses of XNW4107 with imipenem/cilastatin	Experimental	Each subject will receive a total of five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin via IV infusion administered every 6 hours with each administration infused over 60 minutes. Receives: Drug: XNW4107, Imipenem/Cilastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the concentration curve (AUC) from time zero to the last quantifiable sample (AUC0-t) of plasma PK and lung penetration of XNW4107, imipenem and cilastatine in healthy adult volunteers.
Measured: From baseline to 12 hours post- fifth dose
AUC extrapolated to infinity (AUC0-∞) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Measured: From baseline to 12 hours post- fifth dose
AUC from time zero to 6 hours after start of the infusion (AUC0-6) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Measured: From baseline to 6 hours post- fifth dose
Maximum concentration (Cmax) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Measured: From baseline to 12 hours post- fifth dose
Minimum concentration (Cmin) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Measured: From baseline to 12 hours post- fifth dose
Time to Cmax (tmax) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Measured: From baseline to 12 hours post- fifth dose
The terminal-phase half-life (t1/2) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Measured: From baseline to 12 hours post- fifth dose

Secondary outcomes (7)

Number of participants with treatment-related adverse events of Hematology as assessed by CTCAE v5.0
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Hematology including White cell count with differential (total and % of neutrophil, lymphocyte, monocyte, eosinophil, and basophil), red blood cell count in m/mm³, hemoglobin in g/dL, hematocrit in % and platelet count m/mm³.
Measured: From baseline up to Day 9
Number of participants with treatment-related adverse events of Coagulation as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Coagulation including Prothrombin time in seconds, activated partial thromboplastin time in seconds and International Normalized Ratio (INR).
Measured: From baseline up to Day 9
Number of participants with treatment-related adverse events of Biochemistry as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Biochemistry including Sodium in mmol/L, calcium in mg/dL, phosphate in mg/dL, potassium in mmol/L, chloride in mmol/L, glucose in mg/ dl, BUN in mg/dl, uric acid in mg/dl, creatinine in mg/dL, creatine kinase in IU/L, creatinine clearance calculated in ml/ min/1.73m² , total bilirubin in mg/dL, direct bilirubin in mg/dL, alkaline phosphatase in IU/L, ALT in IU/L, AST in IU/L, lactate dehydrogenase in IU/L, gamma-glutamyl transferase in IU/L, total protein in g/dL, albumin in g/dL, triglycerides in mg/dL, and cholesterol in mg/dL.
Measured: From baseline up to Day 9
Number of participants with treatment-related adverse events of Urinalysis as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Urinalysis Specific gravity, pH, leukocyte esterase, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen. [Time
Measured: From baseline up to Day 9
Number of participants with treatment-related adverse events of Physical Examination as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in Physical Examination of the following body systems: HEENT; cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance, and in kilograms, height in meters and weight and height will be combined to report BMI in kg/m².
Measured: From baseline up to Day 9
Number of participants with treatment-related adverse events of Vital Signs as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in Vital Signs (Systolic and diastolic blood pressure in mmHg, heart rate in Beats per min, respiratory rate in Breaths per min, and oral temperature in Degree celsius).
Measured: From baseline up to Day 9
Number of participants with treatment-related adverse events of 12-Lead Electrocardiogram (ECG) as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in 12-Lead Electrocardiogram including heart rate(bpm), RR interval(ms), PR interval(ms), QRS(ms), QT(ms) and QTcF(ms).
Measured: From baseline up to Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 202130 Sep 2021

First posted17 Mar 2021
Study start25 Mar 2021
Primary completion15 May 2021
Study completion30 Sep 2021

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 Bacterial InfectionsStudies of the same condition, open and under way.
More trials run by Evopoint Biosciences Inc.The sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04802863
Sponsor's protocol ID: XNW4107-004
Status last verified: Feb 2023
First submitted: 2 Mar 2021
Last updated: 16 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Rodvold K, Gotfried M, Kocharyan A, Mamikonyan G, Shi Q, Zhao H, Hu T, Xu A, Le M, Li J. Plasma and intrapulmonary pharmacokinetics of funobactam, a novel diazabicyclooctane beta-lactamase inhibitor, administered in combination with imipenem/cilastatin in healthy subjects. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0052426. doi: 10.1128/aac.00524-26. Epub 2026 Jun 15.
PubMed 42294651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects
ClinicalTrials.gov ID: NCT04802863
Acronym / sponsor ID: XNW4107-004
Conditions: Bacterial Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
Study start: 25 Mar 2021 (actual)
Primary completion: 15 May 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 17 Mar 2021 (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 a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Five doses of XNW4107 with imipenem/cilastatin	Experimental	Drug: XNW4107, Imipenem/CilastatinEach subject will receive a total of five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin via IV infusion administered every 6 hours with each administration infused over 60 minutes.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

1． Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening;
2. BMI ≥ 18.5 and ≤ 32 (kg/m²) and weight between 55.0 and 100.0 kg (both inclusive);
3. Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry, coagulation and urinalysis;
4. Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening;
5. Non-smoker (with no use of other tobacco, nicotine or marijuana-containing products, in any form), as documented by history (no nicotine or marijuana use within 3 months prior to Screening);

Key exclusion criteria (15 listed)

1. History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant;
2. Recent history (within 6 months) of known or suspected Clostridium difficile infection;
3. History of seizure disorder;
4. Positive testing for human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab);
5. Positive RT-PCR testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;

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
XNW4107, Imipenem/CilastatinFive doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin	Drug	Five doses of XNW4107 with imipenem/cilastatin

Primary outcome

Area under the concentration curve (AUC) from time zero to the last quantifiable sample (AUC0-t) of plasma PK and lung penetration of XNW4107, imipenem and cilastatine in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
AUC extrapolated to infinity (AUC0-∞) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
AUC from time zero to 6 hours after start of the infusion (AUC0-6) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 6 hours post- fifth dose
Maximum concentration (Cmax) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
Minimum concentration (Cmin) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
Time to Cmax (tmax) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
The terminal-phase half-life (t1/2) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose

7 secondary outcomes

Number of participants with treatment-related adverse events of Hematology as assessed by CTCAE v5.0
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Coagulation as assessed by CTCAE v5.0.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Biochemistry as assessed by CTCAE v5.0.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Urinalysis as assessed by CTCAE v5.0.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Physical Examination as assessed by CTCAE v5.0.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Vital Signs as assessed by CTCAE v5.0.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of 12-Lead Electrocardiogram (ECG) as assessed by CTCAE v5.0.
Time frame: From baseline up to Day 9

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 16 Feb 2023.
Derived from this study: PubMed 42294651Rodvold K, Gotfried M, Kocharyan A, Mamikonyan G, Shi Q, Zhao H, Hu T, Xu A, Le M, Li J. Plasma and intrapulmonary pharmacokinetics of funobactam, a novel diazabicyclooctane beta-lactamase inhibitor, administered in combination with imipenem/cilastatin in healthy subjects. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0052426. doi: 10.1128/aac.00524-26. Epub 2026 Jun 15.
Individual participant dataSharing planned: No

Related trials for Bacterial Infections

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A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 XNW4107, Imipenem/Cilastatin in people with Bacterial Infections, run by Evopoint Biosciences Inc. 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 15 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 16 Feb 2023. 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?

Area under the concentration curve (AUC) from time zero to the last quantifiable sample (AUC0-t) of plasma PK and lung penetration of XNW4107, imipenem and cilastatine in healthy adult volunteers. (time frame: From baseline to 12 hours post- fifth dose). The study lists 7 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 NCT04802863, 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 16 Feb 2023.