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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 four parts: Part A (single-ascending dose), Part B (multiple-ascending dose), optional Part C (adaptive single- and/or multiple-ascending dose), and Part D (relative bioavailability of a tablet formulation of TLC-1180). Up to 72, 100, 100, and 8 healthy subjects will be recruited in Parts A, B, C, and D, respectively. The effect of food on TLC-1180 PK will also be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Solution | Experimental | Oral solution of TLC-1180 |
|
| Tablet | Experimental | Tablet formulation of TLC-1180 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC-1180 Oral Solution | Drug | Oral solution of TLC-1180 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related. | Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study |
| PK of TLC-1180 AUC | Area under the concentration-time curve | Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study |
| PK of TLC-1180 Cmax | Maximum plasma concentration | Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study |
| PK of TLC-1180 tmax | Time to reach Cmax | Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study |
| PK of TLC-1180 t1/2 | Half-life | Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study |
| PK of TLC-1180 CL/F | Apparent clearance, calculated as dose/AUC0-inf | Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Huss, MD | Contact | 650-382-2225 | Clinicaltrials_Inquires@orsobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrsoBio Research Site | Recruiting | Auckland | New Zealand |
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| TLC-1180 Tablet |
| Drug |
Tablet formulation of TLC-1180 |
|
| Placebo Oral Solution | Other | Placebo-to-match oral solution TLC-1180 |
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| Placebo Tablet | Other | Placebo-to-match tablet formulation of TLC-1180 |
|