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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2019-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TD-5202 for SAD (Part A)

6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202

Group Type EXPERIMENTAL

TD-5202

Intervention Type DRUG

Study Drug to be administered orally

Placebo for SAD (Part A)

2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to be administered orally

TD-5202 for MAD (Part B)

6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202

Group Type EXPERIMENTAL

TD-5202

Intervention Type DRUG

Study Drug to be administered orally

Placebo for MAD (Part B)

2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to be administered orally

Interventions

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TD-5202

Study Drug to be administered orally

Intervention Type DRUG

Placebo

Placebo to be administered orally

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes