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A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV

NCT06206720 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-23

No results posted yet for this study

Summary

To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.

Conditions

  • Respiratory Syncytial Virus Infection

Interventions

DRUG

Deuremidevir Hydrobromide for Suspension

15 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg TID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension 3 times every day, total 15 times.

DRUG

Placebo

15 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg TID group: 5 subjects will receive placebo 3 times every day, total 15 times.

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • lanjuan li · Shulan (Hangzhou) Hospital

  • Zhen Qin · Shulan (Hangzhou) Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-06-16
Completion
2025-06-16

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06206720 on ClinicalTrials.gov