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

NCT05940883 | Completed Phase 1 FDA Drug

• 1 other identifier: SIM0308-Y-2-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Adverse Events（Part 1)

  To evaluate the safety and tolerability following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.

  Until follow-up（Day26）or early termination

• Maximum concentration（Cmax）in Part 2 healthy adult subjects

  To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.

  Day1，Day2， Day6，Day7，Day11，Day12

• Time for Cmax (Tmax) in Part 2 healthy adult subjects

  To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.

  Day1，Day2， Day6，Day7，Day11，Day12

• Area under the curve (AUC) in Part 2 healthy adult subjects

  To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.

  Day1，Day2， Day6，Day7，Day11，Day12

• Terminal elimination half-life（t1/2） in Part 2 healthy adult subjects

  To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.

  Day1，Day2， Day6，Day7，Day11，Day12

Secondary Outcomes (5)

• Maximum concentration（Cmax）in Part 1 healthy adult subjects

  Day1，Day2，Day6 and Day18 to Day20

• Time for Cmax (Tmax) in Part 1 healthy adult subjects

  Day1，Day2，Day6 and Day18 to Day20

• Area under the curve (AUC) in Part 1 healthy adult subjects

  Day1，Day2，Day6 and Day18 to Day20

• Terminal elimination half-lifet（1/2 ）in Part 1 healthy adult subjects

  Day1，Day2，Day6 and Day18 to Day20

• Adverse Events（Part 2)

  Until follow-up（Day18）or early termination

Study Arms (6)

Y-2 sublingual tablet dose group 1

EXPERIMENTAL

Drug: Y-2 Sublingual Tablet

Y-2 sublingual tablet dose Group 2

EXPERIMENTAL

Drug: Y-2 Sublingual Tablet

Y-2 sublingual tablet dose Group 3

EXPERIMENTAL

Drug: Y-2 Sublingual Tablet

Y-2 sublingual tablet dose Group 4

EXPERIMENTAL

Drug: Y-2 Sublingual Tablet

Y-2 sublingual tablet dose Group 5

EXPERIMENTAL

Drug: Y-2 Sublingual Tablet

Placebo

PLACEBO COMPARATOR

Certain subjects in group 1 and group 2 will receive placebo.

Drug: Placebo

Interventions

Y-2 Sublingual Tablet DRUG

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.

Y-2 sublingual tablet dose group 1

Placebo DRUG

Placebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight ≥ 50kg at screening.
• A condition of general good health, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
• A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following condition applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 Contraceptive Guidance, OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 1 Contraceptive Guidance from screening through at least 90 days after the last dose of study drug; a WOCBP must have a negative beta-human chorionic gonadotropin (β-hCG) test at screening and baseline prior to administration of investigational product.

You may not qualify if:

• Subject has a history of any clinically significant cardiac, respiratory (including asthma, bronchospasm), renal, hepatic,gastrointestinal, psychiatric, neurologic, hematologic or rheumatic disease, or psychiatric disease or disorder, current acute or chronic infections, or other abnormality that may affect safety, or potentially influence the study results, judged by the investigator or designee.
• Evidence or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
• Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 90 days or 5 half-lives (whichever is longer) prior to Day 1.
• Receipt of any investigational product within 30 days or 5 halflives (whichever is longer) prior to Day 1.
• Will have vaccination with live virus, attenuated live virus, or any live viral components within the 30 days prior to Day 1 or is to receive these vaccines at any time during study period or within 90 days after last dose.
• Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug.
• Male subject who is considering fathering a child or donating sperm during the study or for approximately 90 days after the last dose of study drug.
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to enroll this study.

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (1)

Parexel International Los Angeles Early Phase Clinical Unit

Glendale, California, 91206, United States

Location

Study Officials

• David Han, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 11, 2023
• Study Start: September 6, 2023
• Primary Completion: November 21, 2023
• Study Completion: December 5, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)