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

NCT04801043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-02-16

No results posted yet for this study

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

Interventions

DRUG

XNW4107

XNW4107 250mg IV over 60 minutes as a single dose

DRUG

Imipenem/Cilastatin

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

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

Sponsors & Collaborators

  • Evopoint Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-10-30
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801043 on ClinicalTrials.gov