HealthyPhase 1NCT05940883
A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects
A Phase 1 study testing Y-2 Sublingual Tablet in people with Healthy, run by Simcere Pharmaceutical Co., Ltd at 1 site in United States.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Y-2 Sublingual Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2023to 5 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International Los Angeles Early Phase Clinical Unit
Glendale, California, 91206
About this study
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
This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- Y-2 Sublingual Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-2 Sublingual TabletDrug
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 TabletDrug
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 TabletDrug
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 TabletDrug
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 TabletDrug
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.
PlaceboDrug
Placebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects.
| Study group | Role | What they receive |
|---|---|---|
| Y-2 sublingual tablet dose group 1 | Experimental | Not described Receives: Drug: Y-2 Sublingual Tablet |
| Y-2 sublingual tablet dose Group 2 | Experimental | Not described Receives: Drug: Y-2 Sublingual Tablet |
| Y-2 sublingual tablet dose Group 3 | Experimental | Not described Receives: Drug: Y-2 Sublingual Tablet |
| Y-2 sublingual tablet dose Group 4 | Experimental | Not described Receives: Drug: Y-2 Sublingual Tablet |
| Y-2 sublingual tablet dose Group 5 | Experimental | Not described Receives: Drug: Y-2 Sublingual Tablet |
| Placebo | Placebo comparator | Certain subjects in group 1 and group 2 will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day1，Day2， Day6，Day7，Day11，Day12
Secondary outcomes (5)
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.
Measured: Day1，Day2，Day6 and Day18 to Day20
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.
Measured: Day1，Day2，Day6 and Day18 to Day20
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.
Measured: Day1，Day2，Day6 and Day18 to Day20
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.
Measured: Day1，Day2，Day6 and Day18 to Day20
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.
Measured: Until follow-up（Day18）or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start6 Sep 2023
- Primary completion21 Nov 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Han, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940883
- Sponsor's protocol ID
- SIM0308-Y-2-101
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05940883
- Acronym / sponsor ID
- SIM0308-Y-2-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: PlaceboCertain subjects in group 1 and group 2 will receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-2 Sublingual TabletSubjects 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 dose group 1 |
| Y-2 Sublingual TabletSubjects 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 dose Group 2 |
| Y-2 Sublingual TabletSubjects 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 dose Group 3 |
| Y-2 Sublingual TabletSubjects 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 dose Group 4 |
| Y-2 Sublingual TabletSubjects 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 | Y-2 sublingual tablet dose Group 5 |
| PlaceboPlacebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects. | Drug | Placebo |
Primary outcome
Adverse Events（Part 1)
Time frame: Until follow-up（Day26）or early termination
To evaluate the safety and tolerability following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.
Maximum concentration（Cmax）in Part 2 healthy adult subjects
Time frame: Day1，Day2， Day6，Day7，Day11，Day12
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.
Time for Cmax (Tmax) in Part 2 healthy adult subjects
Time frame: Day1，Day2， Day6，Day7，Day11，Day12
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.
Area under the curve (AUC) in Part 2 healthy adult subjects
Time frame: Day1，Day2， Day6，Day7，Day11，Day12
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.
Terminal elimination half-life（t1/2） in Part 2 healthy adult subjects
Time frame: Day1，Day2， Day6，Day7，Day11，Day12
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.
5 secondary outcomes
Maximum concentration（Cmax）in Part 1 healthy adult subjects
Time frame: Day1，Day2，Day6 and Day18 to Day20
Time for Cmax (Tmax) in Part 1 healthy adult subjects
Time frame: Day1，Day2，Day6 and Day18 to Day20
Area under the curve (AUC) in Part 1 healthy adult subjects
Time frame: Day1，Day2，Day6 and Day18 to Day20
Terminal elimination half-lifet（1/2 ）in Part 1 healthy adult subjects
Time frame: Day1，Day2，Day6 and Day18 to Day20
Adverse Events（Part 2)
Time frame: Until follow-up（Day18）or early termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Han, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Y-2 Sublingual Tablet in people with Healthy, run by Simcere Pharmaceutical Co., Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events（Part 1) (time frame: Until follow-up（Day26）or early termination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.