NCT04243083

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

A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects To Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Of TLL018 Following Oral Administration And With An Open Label Food Effect Panel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: TLL Pharmaceutical, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	TLL018 tablet, placebo	Oral QD

Timeline

• Start date: 2020-01-26
• Primary completion: 2020-12-23
• Completion: 2021-01-31
• First posted: 2020-01-28
• Last updated: 2021-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study