NCT05940883

A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects

A 2-Part, Randomized, Phase I Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Y-2 Sublingual Tablet	Subjects will receive one Y-2 sublingual tablet sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18.
DRUG	Y-2 Sublingual Tablet	Subjects will receive two Y-2 sublingual tablets sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18.
DRUG	Y-2 Sublingual Tablet	Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition A, Day 6 with condition B and Day 11 with condition C.
DRUG	Y-2 Sublingual Tablet	Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition B, Day 6 with condition C and Day 11 with condition A.
DRUG	Y-2 Sublingual Tablet	Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition C, Day 6 with condition A and Day 11 with condition B.
DRUG	Placebo	Placebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects.

Timeline

• Start date: 2023-09-06
• Primary completion: 2023-11-21
• Completion: 2023-12-05
• First posted: 2023-07-11
• Last updated: 2023-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study