Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: TD-5202
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 19 - 55 years old Willing and able to give informed consent and comply with the study Medically healthy with no clinically significant medical history Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method Males must use acceptable contraception Additional inclusion criteria apply Exclusion Criteria: Positive for hepatitis A, B or C, HIV or tuberculosis Clinically significant abnormalities of laboratory evaluations Have abnormal ECG or vital sign measurements Any acute illness at time of screening Have a current bacterial, parasitic, fungal or viral infection Uses or have used tobacco or nicotine-containing products within 6 months prior to screening Additional inclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-5202 for SAD (Part A)<br>6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202 | Drug: TD-5202<br>* Study Drug to be administered orally<br>|
| Placebo Comparator: Placebo for SAD (Part A)<br>2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo | Drug: Placebo<br>* Placebo to be administered orally<br>|
| Experimental: TD-5202 for MAD (Part B)<br>6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202 | Drug: TD-5202<br>* Study Drug to be administered orally<br>|
| Placebo Comparator: Placebo for MAD (Part B)<br>2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo. | Drug: Placebo<br>* Placebo to be administered orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events |  | Day 1 through Day 8 | 
| To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events |  | Day 1 through Day 17 | 
| Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC | Area under the plasma concentration-time curve (AUC) | Day 1 through Day 4 | 
| Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax | Maximum observed concentration (Cmax) | Day 1 through Day 4 | 
| Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax | Time to reach maximum observed concentration (Tmax) | Day 1 through Day 4 | 
| PK of TD-5202 when given as an SAD: CL/F | Oral Clearance (CL/F) | Day 1 through Day 4 | 
| PK of TD-5202 when given as an SAD: Vz/F | Terminal Phase Volume of Distribution(Vz/F) | Day 1 through Day 4 | 
| PK of TD-5202 when given as an SAD: Kel | Elimination Rate (Kel) | Day 1 through Day 4 | 
| PK of TD-5202 when given as an SAD: t 1/2 | Halflife (t 1/2) | Day 1 through Day 4 | 
| PK of TD-5202 when given as an MAD: AUC | Area under the plasma concentration-time curve (AUC) | Day 1 and Day 10 | 
| PK of TD-5202 when given as an MAD: Cmax | Maximum observed concentration (Cmax) | Day 1 and Day 10 | 
| PK of TD-5202 when given as an MAD: Tmax | Time to reach maximum observed concentration (Tmax) | Day 1 and Day 10 | 
| PK of TD-5202 when given as an MAD: C trough | concentration at trough (after multiple dosing usually after reaching steady state) (C trough) | Day 2, 4, 6, 8 | 
| PK of TD-5202 when given as an MAD: Css | concentration at steady state (Css) | Day 10 | 
| PK of TD-5202 when given as an MAD: CL/Fss | Oral clearance at steady state (CL/Fss) | Day 10 | 
| PK of TD-5202 when given as an MAD: Cmin | Concentration minimum (after single dosing) (Cmin) | Day 10 | 
| PK of TD-5202 when given as an MAD: Vz/Fss | Terminal phase volume of distribution at steady state (Vz/Fss) | Day 10 | 
| PK of TD-5202 when given as an MAD: Kel | Elimination Rate (Kel) | Day 10 | 
| PK of TD-5202 when given as an MAD: t 1/2 | Halflife (t 1/2) | Day 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TD-5202, 0177, single ascending dose, SAD, multiple ascending dose, MAD, first-in-human, Phase 1