Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.

Detailed Description
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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.

Official Title
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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: TT-00920
* Drug: TT-00920 Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose 1 (Low dose)<br>TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. | Drug: TT-00920<br>* TT-00920 Tablets<br>|
| Active Comparator: Dose 2 (High dose)<br>TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. | Drug: TT-00920<br>* TT-00920 Tablets<br>|
| Placebo Comparator: Placebo<br>TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. | Drug: TT-00920 Placebo<br>* TT-00920 Placebo Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability] | 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 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Trough plasma concentration (Ctrough) |  | 14 days | 
| Accumulation ratio (Rac) |  | 14 days | 
| Average concentration (Cav) |  | 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 |