TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03103412

Enrollment

Registered

2017-04-06

Start date

2017-05-04

Completion date

2017-11-08

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

Keywords

Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

Brief summary

This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.

Interventions

DRUGTD-3504

TD-3504

DRUG15N2-tofacitinib

15N2-tofacitinib

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female between 18 to 55 years old * Male subjects must abstain from sexual intercourse or use a highly effective method of birth control * 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 * Body Mass Index (BMI) 18 to 32 kg/m2 * Willing and able to give informed consent * Additional inclusion criteria apply Inclusion Criteria for Ulcerative Colitis (UC) subjects: * Subject has a history of UC * Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days * Additional inclusion criteria apply

Exclusion criteria

* Is positive for hepatitis A, B or C, HIV or tuberculosis * Has clinically significant abnormalities in baseline laboratory evaluations * Subject has a clinically significant abnormal electrocardiogram (ECG) * 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) * Additional

Design outcomes

Primary

Measure	Time frame	Description
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events	Day 1 through Day 8	To assess the safety & tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.

Secondary

Measure	Time frame	Description
Systemic area under the curve of TD-3504	Day 1 through Day 4	To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of TD-3504	Day 1	To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic area under the curve of tofacitinib	Day 1 through Day 4	To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of tofacitinib	Day 1	To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values	Day 1 through Day 8	To assess the safety & tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing treatment related changes safety laboratory values.
Systemic Cmax of 15N2-tofacitinib	Day 1	To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Tofacitinib relative bioavailability by area under the curve comparison	Day 1 through Day 4	To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Tofacitinib relative bioavailability by Cmax comparison	Day 1	To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Systemic area under the curve of 15N2-tofacitinib	Day 1 through Day 4	To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026