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

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo for MAD; Drug: TD-1473 for MAD; Drug: TD-1473 for SAD; Drug: Placebo for SAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02657122

0140

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups, including a placebo group

TD-1473 for SAD

Experimental group

Description:

6 of out 8 subjects per cohort will be randomized to receive TD-1473

Treatment:

Drug: TD-1473 for SAD

Placebo for SAD

Placebo Comparator group

Description:

2 of out 8 subjects per cohort will be randomized to receive placebo

Treatment:

Drug: Placebo for SAD

TD-1473 for MAD

Experimental group

Description:

6 of out 8 subjects per cohort will be randomized to receive TD-1473

Treatment:

Drug: TD-1473 for MAD

Placebo for MAD

Placebo Comparator group

Description:

2 of out 8 subjects per cohort will be randomized to receive placebo

Treatment:

Drug: Placebo for MAD