NCT06328400

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

A Multiple-dose, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Two groups are initially set up, starting from Group 1 and progressing sequentially to Group 2. After all volunteers in the first group (900 mg BID group) complete the safety follow-up on the 4th day after the last dose (i.e. D10), the safety information and PK data will be reviewed jointly by the researchers and sponsors before the second group of volunteers starting administration. The preferred dose for the second group is 900 mg TID, and if there are safety risks found after the Group 1 study, it will be adjusted to 1200 mg BID or other appropriate dosage and frequency. A total of 24 volunteers are planned to be enrolled, with 12 volunteers in each group. The trial drug and placebo will be allocated in a 3:1 ratio, with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-27
• Primary completion: 2024-05-06
• Completion: 2024-05-06
• First posted: 2024-03-25
• Last updated: 2024-10-01

Locations

1 site across 1 country: China