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A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study of TLL018, With Food Effect, in Healthy Participants

NCT04243083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-03-30

No results posted yet for this study

Summary

TLL018 is developed for treatment of autoimmune and inflammatory diseases including rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses TLL018 is safe and can be tolerated when administered to humans, (2) assessing what TLL018 does to the body and how the body responds to TLL018 when given as single and multiple doses, and (3) assessing potential food effect on TLL018.

Conditions

  • Healthy

Interventions

DRUG

TLL018 tablet, placebo

Oral QD

Sponsors & Collaborators

  • TLL Pharmaceutical, LLC

    lead INDUSTRY

Principal Investigators

  • Frank Lee, MD · Frontage Clinical Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-26
Primary Completion
2020-12-23
Completion
2021-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04243083 on ClinicalTrials.gov