NCT06093308

A Study in Elderly Chinese Subjects With Underlying Diseases

A Phase 1, Open-label, Single-and Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JT001 Administered Orally in Elderly Chinese Subjects With Underlying Diseases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and tolerability of oral JT001 tablets in elderly subjects with underlying diseases. Evaluate the pharmacokinetic characteristics of JT001 tablets orally administered to elderly subjects with underlying diseases. Explore the drug drug interactions between JT001 tablets and some drugs in elderly subjects with underlying diseases who have been orally administered multiple times.

Detailed description

The open-label, single-center phase I study to evaluate the safety, tolerability, and pharmacokinetics of JT001 single-and multiple-dose administered orally in elderly subjects with underlying diseases.Approximately 16 to 18 elderly subjects will be enrolled aging beyound 60 years. All subjects received JT001, oral administration after meals, D1: 0.6g, twice a day; D2-D5: 0.3g, twice a day; D6: 0.3g, administered once in the morning.Blood samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in elderly groups.The steady-state trough concentration of therapeutic drug monitoring (TDM) for the basic medication of the subjects will be collected as well. Subjects will be admitted to the phase I clinical trial ward 2 days before administration (D-2) and will not be allowed to leave until all examinations and assessments are completed on day 8. Telephone follow-up will be performed on day 12 (±1 day).

Conditions

• Elderly Subjects With Underlying Diseases

Interventions

Type	Name	Description
DRUG	Deuremidevir Hydrobromide Tablets	Multiple administration, oral administration after meals, D1: 0.6g, twice a day; D2-D5: 0.3g, twice a day; D6: 0.3g, administered once in the morning

Timeline

• Start date: 2023-07-12
• Primary completion: 2023-08-25
• Completion: 2023-08-25
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: China