Healthy
Conditions
Brief summary
This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.
Detailed description
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.
Interventions
DRUGTT-00920
Tablets
DRUGTT-00920 Placebo
Tablets
Sponsors
TransThera Sciences (Nanjing), Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent must be obtained * Age ≥ 18.0 years and ≤ 55.0 years, male or female * BMI between 18.0 and 30.0 kg/m2, inclusive, and male weighs at least 50.0 kg and female weighs at least 45.0 kg
Exclusion criteria
* Known hypersensitivity or allergy to lactose * Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration * Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality * Subject with a history of severe visual diseases; or visual changes * Subject is unable to complete this study for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinically relevant changes in vital signs | 20 days | Vital signs include temperature, respiratory rate, blood pressure and pulse |
| Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG) | 20 days | A standard 12-lead ECG was performed. |
| Percentage of Participants With Clinically relevant changes in clinical laboratory tests | 20 days | Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis. |
| Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator | 20 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Derived multiple dose PK parameters | 20 days | AUC0 t, ss |
| Derived single dose PK parameters | 20 days | AUC0 t |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL) | 20 days | cGMP: cyclic guanosine monophosphate |
| Urine PK parameters Feurine% | 20 days | Feurine%: Fraction of drug excreted in urine |
| Urine PK parameters | 20 days | Aet |
| 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 | 20 days | An actionable genotype is defined as the presence of at least one mutation that is used to guide a drug/dose modification |
| TT-00920 metabolites as compared to baseline | 20 days | AUC of observed drug-related material in plasma to determine the presence of any metabolite \>10% |
Countries
China
Outcome results
None listed