To Evaluate the Pharmacokinetics of XNW4107 in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.

NCT ID: NCT04801043

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2022-01-31

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females.

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: Healthy young females

Healthy young females participants, ≥ 18 to ≤ 45 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg.

Group Type: EXPERIMENTAL

XNW4107

Intervention Type: DRUG

XNW4107 250mg IV over 60 minutes as a single dose

Imipenem/Cilastatin

Intervention Type: DRUG

500mg/500mg IV over 60 minutes as a single dose

Cohort 2: Healthy elderly males

Healthy elderly male participants, ≥ 65 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg.

Group Type: EXPERIMENTAL

XNW4107

Intervention Type: DRUG

XNW4107 250mg IV over 60 minutes as a single dose

Imipenem/Cilastatin

Intervention Type: DRUG

500mg/500mg IV over 60 minutes as a single dose

Cohort 3: Healthy elderly females

Healthy elderly female participants, ≥ 65 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg.

Group Type: EXPERIMENTAL

XNW4107

Intervention Type: DRUG

XNW4107 250mg IV over 60 minutes as a single dose

Imipenem/Cilastatin

Intervention Type: DRUG

500mg/500mg IV over 60 minutes as a single dose

Placebo to XNW 4107 & imipenem/cilastatin

Matching placebo for XNW4107 and imipenem/cilastatin

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Matching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose

Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose

Interventions

XNW4107

XNW4107 250mg IV over 60 minutes as a single dose

Intervention Type: DRUG

Imipenem/Cilastatin

500mg/500mg IV over 60 minutes as a single dose

Intervention Type: DRUG

placebo

Matching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose

Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Healthy adult female, 18 to 45 years of age (both inclusive) or 65 years or over (≥ 65 years); or healthy adult male 65 years or over (≥ 65 years).

2. BMI ≥ 18.0 and ≤ 32.0 (kg/m²) and weight between 55.0 and 100.0 kg (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 and urinalysis.

4. Male or female, willing to contracept. If female, must be non-pregnant and non-lactating.

5. 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 48 hours prior to study drug administration until discharge from the clinical unit.

Exclusion Criteria

• 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. Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females obtained after at least 5 minutes in a supine or semi-supine position at quiet rest at Screening or Check-In (Day -1).

3. Subjects who have any of the following abnormalities on laboratory values at Screening or prior confinement including: • White blood cell count < 3,000/mm³, hemoglobin < 11g/dL; • Absolute neutrophil count <1,200/mm³, platelet count <120,000/mm³; • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory.

4. History of seizure disorder except childhood history of febrile seizures.

5. Positive 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.

7. Recent history (within 6 months) of known or suspected Clostridium difficile infection.

8. Positive testing for HIV Ab, HBsAg or HCV Ab.

9.Positive urine drug or alcohol testing at screening or check-in (Day -1).

10.Use of prescription medications (with the exception of hormone replacement therapy and contraceptives), 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. Receipt of an investigational drug within 30 days or 5 half-lives prior to the first administration of study drug, whichever is longer.

12. Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication, or history of clinically significant hypersensitivity to the study drug or any related drugs or to any of the excipients, or significant food intolerance.

13. Donation of blood or plasma within 30 days prior to dosing, or loss of whole blood of more than 500 mL within 30 days prior to dosing, or receipt of a blood transfusion within 1 year of study enrollment.

14. Any other condition or prior therapy, which, in the opinion of the Investigator, would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Evopoint Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orlando Clinical Research Center (OCRC)

Orlando, Florida, United States

Countries

United States

Other Identifiers

XNW4107-002

Identifier Type: -

Identifier Source: org_study_id