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Bacterial InfectionsPhase 1NCT04482569

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin

A Phase 1 study testing XNW4107 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 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bacterial Infections
What is being tested?
XNW4107
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
10 Jul 2020to 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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male adults aged 18-65 years
  • Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
  • In good general health, as determined by the Investigator, based on medical history, physical examination, 12 lead electrocardiogram (ECG), vital sign (VS) measurements, and laboratory test results.
  • Normal blood pressure (BP), defined as: systolic BP (SBP) ≥90 mmHg and ≤140 mmHg; and diastolic BP (DBP) <90 mmHg at the time of Screening
  • Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) in addition to an acceptable method (female partner) of contraception for the duration of the study and for at least 90 days post last dose.
  • Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), hepatitis E immunoglobulin M antibody (IgM anti HEV), and Treponema pallidum antibody chemiluminescent immunoassay (TP IA).
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  • Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), hepatitis E immunoglobulin M antibody (IgM anti HEV), and Treponema pallidum antibody chemiluminescent immunoassay (TP IA).
  • Non smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 3 months prior to Screening)
  • Negative results for drugs of abuse, alcohol, and cotinine at Screening and Admission

Who cannot join

  • History of clinically significant psychiatric disorder within the past 5 years.
  • History of stroke, chronic seizures, or other major neurological disorder.
  • History or evidence of drug/alcohol abuse within 1 year prior to Screening.
  • History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or disease.
  • History of cancer (malignancy).
  • History of any illness that, in the opinion of the study investigator, may confound the results of the study or pose additional risk to the subject if he participates in the study.
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  • Administration of another investigational medication within 30 days (or 5 half lives, whichever is longer) prior to study drug administration.
  • Participation in an investigational device study within 30 days prior to study drug administration.
  • Excessive consumption of alcohol, defined as >3 alcoholic beverages per day (10 ounces of beer [284 mL], 4 ounces of wine [125 mL], or 1 ounce of distilled spirits [25 mL] is approximately equivalent to 1 alcoholic beverage)
  • Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive consumption is defined as >6 servings per day (1 serving contains approximately 120 mg caffeine)
  • History and/or family history of congenital long QT syndrome, unexplained syncope, or other additional risks of Torsade de Pointes or sudden premature death.
  • Any ECG abnormality considered to be clinically significant by the principal investigator (PI)/designee;
  • Glomerular filtration rate (GFR) ≤80 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation.
  • Ongoing liver disease or unexplained liver function test (LFT) elevations
  • History of hypersensitivity to β lactam antibiotics (including, but not limited to imipenem)
  • History of significant multiple and/or severe allergies (including latex allergy);
  • Loss or donation of blood (approximately 500 mL) within 60 days prior to study drug administration on Day 1, or donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1.
  • History of infectious disease within 28 days prior to study drug administration on Day 1 that, in the opinion of the investigator, would affect the subject's ability to participate in the trial.
  • Venous access considered inadequate for PK sample collection and IV infusion; history or evidence of adverse symptoms associated with IV access, phlebotomy, or blood donation.
  • Employee or family member of the investigator, study site personnel, or sponsor.
  • Any other clinically relevant abnormality in the opinion of the investigators from the following: medical and/or surgical history, physical examination, vital signs, 12-lead ECG, serum chemistry, hematology, and urinalysis.
  • Any other reason that, in the opinion of the investigator, would render the subject unsuitable for study enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pharmaron CPC

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double Blind, Placebo Controlled Sequential Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of XNW4107 for Injection, and Multiple Doses of XNW4107 for Injection in Combination With Imipenem/Cilastatin for Injection in Healthy Adult Male Subjects

This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.

Being tested
XNW4107
Keywords
XNW4107, Pharmacokinetics
Medical subject headings
Bacterial Infections

What participants receive

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

  • XNW4107Drug

    Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin

Study groups in NCT04482569
Study groupRoleWhat they receive
Single Ascending Dose StudyExperimentalSix XNW4107 doses ( 50-1250 mg ), each administered as a single dose with 60-minute IV infusion
Receives: Drug: XNW4107
Multiple Ascending Dose StudyExperimentalThree XNW4107 doses (167-500 mg), each administered as 60-minute IV infusion every 6 hours for 7 days
Receives: Drug: XNW4107
Multiple Dose Study of XNW4107 +Imipenem/CilastatinExperimental500 mg XNW4107 co-administered with imipenem/cilastatin as 60-minute IV infusion every 6 hours for 14 days
Receives: Drug: XNW4107

What is being measured

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

  1. Safety as assessed by number of participants experiencing adverse events

    Number of participants who experience adverse events in different grades, as defined by Common Terminology for Adverse Events (CTCAE) v5.0

    Measured: Change from baseline up to day 43 post-intervention

Timeline

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

  1. First posted22 Jul 2020
  2. Study start10 Jul 2020
  3. Primary completion28 Feb 2021
  4. Study completion30 Sep 2021

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04482569
Sponsor's protocol ID
XNW4107-001
Status last verified
Feb 2023
First submitted
18 Jul 2020
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XNW4107 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 9 inclusion and 22 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?

Safety as assessed by number of participants experiencing adverse events (time frame: Change from baseline up to day 43 post-intervention). 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 NCT04482569.

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.

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