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

Evopoint Biosciences Inc.1 site in 1 country88 target enrollmentJuly 10, 2020

ConditionsBacterial Infections

InterventionsXNW4107

DrugsXNW4107

Overview

Phase: Phase 1
Intervention: XNW4107
Conditions: Bacterial Infections
Sponsor: Evopoint Biosciences Inc.
Enrollment: 88
Locations: 1
Primary Endpoint: Safety as assessed by number of participants experiencing adverse events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.

Registry

clinicaltrials.gov

Start Date

July 10, 2020

End Date

September 30, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Evopoint Biosciences Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).
•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

Exclusion Criteria

•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.
•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)