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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05940883
• Other study ID #: SIM0308-Y-2-101
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: June 2023
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 5, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria

1. Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.

2. Body Mass Index (BMI) = 18 and = 30 kg/m2 and weight = 50kg at screening.

3. 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).

4. 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 (ß-hCG) test at screening and baseline prior to administration of investigational product.

Exclusion Criteria:

1. 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.

2. Evidence or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.

3. 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.

4. Receipt of any investigational product within 30 days or 5 halflives (whichever is longer) prior to Day 1.

5. 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.

6. 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.

7. 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.

8. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to enroll this study.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Parexel International Los Angeles Early Phase Clinical Unit	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Maximum concentration(Cmax)in Part 1 healthy adult subjects	To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.	Day1,Day2,Day6 and Day18 to Day20
Secondary	Time for Cmax (Tmax) in Part 1 healthy adult subjects	To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.	Day1,Day2,Day6 and Day18 to Day20
Secondary	Area under the curve (AUC) in Part 1 healthy adult subjects	To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.	Day1,Day2,Day6 and Day18 to Day20
Secondary	Terminal elimination half-lifet(1/2 )in Part 1 healthy adult subjects	To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.	Day1,Day2,Day6 and Day18 to Day20
Secondary	Adverse Events(Part 2)	To evaluate the safety following different single administration conditions of Y-2 sublingual tablet in healthy adult subjects in part 2.	Until follow-up(Day18)or early termination