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

NCT ID: NCT06206720

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-06-16

Brief 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.

Detailed Description

This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months.

It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.

Conditions

Respiratory Syncytial Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deuremidevir Hydrobromide for Suspension

Deuremidevir Hydrobromide for Suspension will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.

Group Type: EXPERIMENTAL

Deuremidevir Hydrobromide for Suspension

Intervention Type: DRUG

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.

Placebo

Placebo will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

VV116; VV116 placebo

Eligibility Criteria

Inclusion Criteria

1. Male or female infants ≥1 month and ≤24 months；

2. Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；

3. Onset of RSV infection symptoms should be ≤ 5 days；

4. Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；

5. Patient must have a Wang Respiratory Score ≥ 5;

6. Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;

7. The parent/legal guardian must have provided written informed consent for the patient to participate.

Exclusion Criteria

1. Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;

2. Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.

3. Requires vasopressors or inotropic support at the time of enrollment;

4. Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；

5. Patients with hypercapnia (Except for patients who have recovered at the time of screening);

6. Chronic or persistent feeding difficulties;

7. Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;

8. Symptomatic because of inborn errors of metabolism;

9. Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;

10. Patients with congenital heart disease (CHD) with significant hemodynamic changes, except simple CHD (such as patent ductus arteriosus, atrial septal defect or ventricular septal defect without hemodynamic influence).

11. Clinical evidence of hepatic decompensation

12. Renal failure including renal anomalies likely to be associated with renal insufficiency;

13. Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months);

14. Suspected or known to have congenital acquired immunodeficiency;

15. A history of epilepsy or seizures;

16. A history of high allergies;

17. Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment;

18. Participation in an investigational drug or device study within 30 days prior to the date of screening;

19. Failure to satisfy the investigator of fitness to participate for any other reason.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lanjuan li

Role: PRINCIPAL_INVESTIGATOR

Shulan (Hangzhou) Hospital

Zhen Qin

Role: PRINCIPAL_INVESTIGATOR

Shulan (Hangzhou) Hospital

Locations

The first Affiliated hospital of Bengbu Medical University

Bengbu, Anhui, China

Chongqing University Jiangjin Hospital

Chongqing, Chongqing Municipality, China

Xiamen Children's Hospital

Xiamen, Fujian, China

Xiamen Maternity and Child Healthcare Hospital

Xiamen, Fujian, China

Guangdong Women and Children's Hospital and Health Institute

Guangzhou, Guangdong, China

Panyu Maternal and Child care Service centre of Guangzhou

Guangzhou, Guangdong, China

The Sceond Affiliated hospital of Shantou University Medical college

Shantou, Guangdong, China

Shenzhen Guangming District People's Hospital

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Hainan women and children's Medical centre

Haikou, Hainan, China

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Changde First people's Hospital

Changde, Hunan, China

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Maternal and Child Health

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Linfen Central Hospital

Linfen, Shanxi, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Shulan (hangzhou) Hosipital

Hangzhou, Zhejiang, China

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hangzhou First people's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

VV116-RSV-II/III-01

Identifier Type: -

Identifier Source: org_study_id