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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension

NCT06328400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-01

No results posted yet for this study

Summary

This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

Deuremidevir Hydrobromide for Suspension

Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day

DRUG

Deuremidevir Hydrobromide for Suspension Placebo

Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Xiaojie Wu · Hushan Hospital Fudan university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2024-05-06
Completion
2024-05-06

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 NCT06328400 on ClinicalTrials.gov