Healthy
Conditions
Brief summary
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
Detailed description
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.
Interventions
DRUGTT-00920
TT-00920 Tablets
DRUGTT-00920 Placebo
TT-00920 Placebo Tablets
Sponsors
TransThera Sciences (Nanjing), Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 weighs at least 50.0 kg * No clinically significant findings in medical examination
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 * HbA1c \> 5.7 % at Screening * Subject with a history of severe visual diseases; or visual changes * Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability] | 14 days | * TEAE: Treatment emergent adverse events * Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations |
Secondary
| Measure | Time frame |
|---|---|
| Trough plasma concentration (Ctrough) | 14 days |
| Volume of distribution at steady state (Vz/F, ss) | 14 days |
| Clearance at steady state (CL/F, ss) | 14 days |
| Half-life at steady state (T1/2, ss) | 14 days |
| Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss) | 14 days |
| Maximum observed plasma concentration at steady state (Cmax, ss) | 14 days |
| Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss) | 14 days |
| Minimum observed plasma concentration at steady state (Cmin, ss) | 14 days |
| Accumulation ratio (Rac) | 14 days |
| Average concentration (Cav) | 14 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL) | 14 days | cGMP: cyclic guanosine monophosphate |
| Utilization of PGx results | 14 days | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response |
| Metabolite characterization in plasma and estimation | 14 days | observed drug-related material in plasma to determine the presence of any metabolite \>10% |
Countries
United States
Outcome results
None listed