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

NCT ID: NCT05940883

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2023-12-05

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Y-2 sublingual tablet dose group 1

Group Type: EXPERIMENTAL

Y-2 Sublingual Tablet

Intervention Type: 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 2

Group Type: EXPERIMENTAL

Y-2 Sublingual Tablet

Intervention Type: DRUG

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 dose Group 3

Group Type: EXPERIMENTAL

Y-2 Sublingual Tablet

Intervention Type: DRUG

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 dose Group 4

Group Type: EXPERIMENTAL

Y-2 Sublingual Tablet

Intervention Type: DRUG

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 dose Group 5

Group Type: EXPERIMENTAL

Y-2 Sublingual Tablet

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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 (β-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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Han, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Parexel International Los Angeles Early Phase Clinical Unit

Glendale, California, United States

Countries

United States

Other Identifiers

SIM0308-Y-2-101

Identifier Type: -

Identifier Source: org_study_id