NCT06935682

Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Study to Assess the Safety and Pharmacokinetics of Y-4 Tablets After Single- and Multiple-dose in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose. The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.

Detailed description

This study will be a single-center, randomized, double-blind, placebo-controlled, dose-escalation study in Chinese healthy adult subjects. A total of 36 subjects, 3 cohorts of 12 subjects each (half men and half women), will be enrolled in this study. In each dose cohort, subjects will undergo single and multiple (BID, 11 doses) administration, among them, 10 subjects (half men and half women) will receive Y-4 tablets and 2 subjects (half men and half women) will receive placebo randomly. After providing written informed consent, subjects will undergo screening for eligibility. Screening for the study will begin 14 days prior to the dosing. Subjects will be admitted to research center in the afternoon of Day-1 prior to the dosing day and fasting for the next 10 hours overnight. In the morning of the following day (Day 1), subjects will be administered the assigned dose of Y-4 tablets or placebo orally, then subjects will be monitored for the following 72 hours. During Day 5 to Day 9, the subjects will be required to be administered twice a day (Q12 h), once in the morning and once in the evening. In the morning of Day 10, subjects will be administered to the last dose. In the morning of Day 13 (approximately 72 hours after the last administration), the safety and tolerance will be evaluated and then subjects will be discharged. A telephone follow-up/completion visit will be conducted 7 days (±1) post discharge. Treatment cohorts are planned as following: Cohort 1: 75 mg/18.75 mg Y-4 tablets (75 mg pregabalin and 18.75 mg riluzole) or placebo tablets (two little Y-4 tablets) Cohort 2: 112.5 mg/28.125 mg Y-4 tablets (112.5 mg pregabalin and 28.125 mg riluzole) or placebo tablets (one large Y-4 tablet) Cohort 3: 150 mg/37.5 mg Y-4 tablets (150 mg pregabalin and 37.5 mg riluzole) or placebo tablets (one large Y-4 tablet and one little Y-4 tablet)

Conditions

• Healthy Adult Male and Female Volunteers

Interventions

Type	Name	Description
DRUG	Y-4 tables	Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 tablets on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 tablets continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.
DRUG	Y-4 placebos	Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 placebos on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 placebos continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.

Timeline

• Start date: 2025-01-04
• Primary completion: 2025-05-04
• Completion: 2025-06-30
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: China