SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 19 - 55 |
Updated: | 7/1/2016 |
Start Date: | December 2015 |
End Date: | April 2016 |
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
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.
single ascending doses and multiple ascending doses of the investigational drug TD-1473
compared to placebo in healthy subjects.
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
We found this trial at
1
site
Click here to add this to my saved trials