CompletedNCT02657122Updated Jan 19, 2021

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

A Phase 1 interventional study of TD-1473 for SAD and Placebo for SAD in Healthy, sponsored by Theravance Biopharma. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by Theravance Biopharma · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 19 Years to 55 Years
Sex: All

Study summary

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.

Conditions studied

Healthy

Keywords

Single ascending dose
SAD
multiple ascending dose
MAD
Phase 1
first-in-human
volunteers
TD-1473

In context

Lead sponsor

Theravance Biopharma is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 72 participants (actual)

Study arms

Experimental
TD-1473 for SAD
6 of out 8 subjects per cohort will be randomized to receive TD-1473
Drug: TD-1473 for SAD
Placebo comparator
Placebo for SAD
2 of out 8 subjects per cohort will be randomized to receive placebo
Drug: Placebo for SAD
Experimental
TD-1473 for MAD
6 of out 8 subjects per cohort will be randomized to receive TD-1473
Drug: TD-1473 for MAD
Placebo comparator
Placebo for MAD
2 of out 8 subjects per cohort will be randomized to receive placebo
Drug: Placebo for MAD

Interventions

DrugTD-1473 for SAD
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.
DrugPlacebo for SAD
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.
DrugTD-1473 for MAD
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.
DrugPlacebo for MAD
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.

What researchers measure

Primary outcomes

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
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)

Secondary outcomes

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

Study locations

1 site

Celerion
Lincoln, Nebraska 68502, United States

References and documents

Publications

Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049. PubMed 32161949 ↗

Individual participant data

Plan to share: No — Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02657122
Lead sponsor: Theravance Biopharma
Responsible party: Sponsor
First posted: Jan 15, 2016
Start date: Dec 2015
Primary completion: Apr 2016
Completion: Apr 2016
Last update: Jan 19, 2021

Study contacts

Medical Monitor

study director · Theravance Biopharma

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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