This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.
The primary objectives are to assess the safety, tolerability, and plasma PK of TLC-1180 in healthy subjects. The exploratory objective is to evaluate the PD of TLC-1180 in healthy subjects. This study is comprised of three parts: Part A (single-ascending dose), Part B (adaptive multiple-ascending dose), and Part C (adaptive single-ascending dose). Up to 72, 100, and 160 healthy subjects will be recruited in Parts A, B, and C, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
332
Oral solution of TLC-1180
Tablet formulation of TLC-1180
Placebo-to-match oral solution TLC-1180
OrsoBio Research Site
Auckland, New Zealand
RECRUITINGIncidence of TLC-1180 treatment-emergent adverse events
Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v6.0). The relationship between AEs and the study drug will be indicated as related or not related.
Time frame: Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
PK of TLC-1180 AUC
Area under the concentration-time curve
Time frame: Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
PK of TLC-1180 Cmax
Maximum plasma concentration
Time frame: Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
PK of TLC-1180 tmax
Time to reach Cmax
Time frame: Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
PK of TLC-1180 t1/2
Half-life
Time frame: Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
PK of TLC-1180 CL/F
Apparent clearance, calculated as dose/AUC0-inf
Time frame: Through study completion: Day 365 (Parts A, C); up to Day 421 (Part B) of the study
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Placebo-to-match tablet formulation of TLC-1180