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The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of Singletine in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of Singletine in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with Singletine orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.
This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 7-day multiple-dose treatment and 9-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Singletine(DC407) ascending dose | Experimental | Single ascending dose |
|
| Singletine(DC407)food influence group | Experimental | Food influence group |
|
| Singletine placebo comparator(Single ascending dose) | Placebo Comparator | Single ascending dose |
|
| Singletine placebo comparator(food influence group) | Placebo Comparator | Food influence group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Singletine | Drug | Singletine orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Assessment by adverse event monitoring CTCAE 5.0 | First dose of study drug up to 31 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve(AUC) From Time Zero to Last Quantifiable Concentration | Area under the plasma concentration time-curve from zero to the last measured concentration (AUC)last | Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration; |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200020 | China |
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| Placebo | Drug | Placebo orally administered |
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration; |