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This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.
This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10 randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and a single dose on day 7. The study will consist of a Screening Period, an In-house Period and a Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | low dose |
|
| Dose 2 | Experimental | Middle dose |
|
| Dose 3 | Experimental | High dose |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT-00920 | Drug | Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug. | 20 days |
| Percentage of Participants With Clinically relevant changes in vital signs | Vital signs include temperature, respiratory rate, blood pressure and pulse | 20 days |
| Percentage of Participants With Clinically relevant changes in clinical laboratory tests | Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis. | 20 days |
| Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG) | A standard 12-lead ECG was performed. | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Derived multiple dose PK parameters | AUC0 t, ss | 20 days |
| Derived multiple dose PK parameters | Cmax, ss | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| TT-00920 metabolites as compared to baseline | AUC of observed drug-related material in plasma to determine the presence of any metabolite >10% | 20 days |
| Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 320500 | China |
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| TT-00920 Placebo |
| Drug |
Tablets |
|
| Derived multiple dose PK parameters | tmax, ss | 20 days |
| Derived multiple dose PK parameters | Rac | 20 days |
| Derived multiple dose PK parameters | Cav | 20 days |
| Derived multiple dose PK parameters | CL/F, ss | 20 days |
| Derived single dose PK parameters | AUC0 t | 20 days |
| Derived single dose PK parameters | Cmax | 20 days |
| Derived single dose PK parameters | tmax | 20 days |
cGMP: cyclic guanosine monophosphate
| 20 days |
| Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification | An actionable genotype is defined as the presence of at least one mutation that is used to guide a drug/dose modification | 20 days |
| Urine PK parameters | Aet | 20 days |
| Urine PK parameters Feurine% | Feurine%: Fraction of drug excreted in urine | 20 days |