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A Study of AK0529 in Adults Patients Hospitalized With RSV Infection

NCT06942299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-04-24

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, phase II study to be conducted in adults hospitalized with RSV infection in China. The main objectives of this study are to investigate the safety, pharmacokinetics and efficacy of AK0529 in adult RSV patients.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

AK0529

Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting

DRUG

AK0529

Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal

DRUG

Placebo

Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal or fasting

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2024-06-28
Completion
2024-06-28

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 NCT06942299 on ClinicalTrials.gov