A Phase 1 Study 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, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.

Detailed Description
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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. 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.

Official Title
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A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple 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 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

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: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>low dose | Drug: TT-00920<br>* Tablets<br>|
| Experimental: Dose 2<br>Middle dose | Drug: TT-00920<br>* Tablets<br>|
| Experimental: Dose 3<br>High dose | Drug: TT-00920<br>* Tablets<br>|
| Placebo Comparator: Placebo<br> | Drug: TT-00920 Placebo<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Derived multiple dose PK parameters | AUC0 t, ss | 20 days | 
| Derived multiple dose PK parameters | Cmax, ss | 20 days | 
| 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 |