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A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

NCT05895812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-09-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of JT001 in adult subjects with mild and moderate renal impairment compared to healthy mean-matched subjects.The results of this study will guide the clinical recommendation regarding whether or not a dose adjustment may be needed when treating patients with renal impairment.

Conditions

  • Subjects With Renal Impairment
  • Healthy Subjects

Interventions

DRUG

Deuremidevir Hydrobromide Tablets

JT001 single dose, 0.3g

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Vinnerna Biosciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huiyu Lan, Project Director · Shanghai Vinnerna Biosciences Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2023-08-25
Completion
2023-08-28

Countries

  • China

Study Locations

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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 NCT05895812 on ClinicalTrials.gov