SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.

Official Title
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A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: TD-1473 for SAD
* Drug: Placebo for SAD
* Drug: TD-1473 for MAD
* Drug: Placebo for MAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female 19 to 55 years old Willing and able to give informed consent Body Mass Index (BMI) 18 to 30 kg/m2 Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control Additional inclusion criteria apply Exclusion Criteria: Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB) Clinically significant abnormalities in baseline results of laboratory evaluations Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device) Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy. Additional exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 19 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1473 for SAD<br>6 of out 8 subjects per cohort will be randomized to receive TD-1473 | Drug: TD-1473 for SAD<br>* SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.<br>|
| Placebo Comparator: Placebo for SAD<br>2 of out 8 subjects per cohort will be randomized to receive placebo | Drug: Placebo for SAD<br>* SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.<br>|
| Experimental: TD-1473 for MAD<br>6 of out 8 subjects per cohort will be randomized to receive TD-1473 | Drug: TD-1473 for MAD<br>* MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.<br>|
| Placebo Comparator: Placebo for MAD<br>2 of out 8 subjects per cohort will be randomized to receive placebo | Drug: Placebo for MAD<br>* MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs |  | Day 1 through Day 8 (SAD) or 21 (MAD) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve (AUC) in plasma, urine and feces |  | Day 1 through Day 4-6 (SAD) | 
| Cmax in plasma, urine and feces |  | Day 1 through Day 4-6 (SAD) | 
| Tmax in plasma, urine and feces |  | Day 1 through Day 4-6 (SAD) | 
| Terminal elimination half-life (t1/2) in plasma, urine and feces |  | Day 1 through Day 4-6 (SAD) | 
| Amount excreted in urine (Aeu) |  | Day 1 through Day 4-6 (SAD) | 
| Amount excreted in feces (Aef) |  | Day 1 through Day 4-6 (SAD) | 
| AUC in plasma, urine and feces |  | Day 1 through Day 17-19 (MAD) | 
| Cmax in plasma, urine and feces |  | Day 1 through Day 17-19 (MAD) | 
| Tmax in plasma, urine and feces |  | Day 1 through Day 17-19 (MAD) | 
| t1/2 in plasma, urine and feces |  | Day 1 through Day 17-19 (MAD) | 
| Aeu |  | Day 1 through Day 17-19 (MAD) | 
| Aef |  | Day 1 through Day 17-19 (MAD) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single ascending dose, SAD, multiple ascending dose, MAD, Phase 1, first-in-human, volunteers, TD-1473