Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.
The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kylo-0603 | Experimental | In part 1, subjects will receive single dose Kylo-0603 orally at dose levels of 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, 4.6 mg, 8.6 mg, 12 mg, 16 mg and 20 mg on Day 1. In part 2, subjects will receive Kylo-0603 4.6 mg on Day 1 in fasted state and on Day 4 after a standard high-fat meal. In part 3, subject will receive Kylo-0603 orally once daily for 14 days at dose levels of 1.2 mg, 2 mg, 4 mg, 8 mg, 12 mg, and 16 mg. |
|
| Placebo | Placebo Comparator | Subjects will receive matching placebo in part 1, part 2 and part 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kylo-0603 capsule | Drug | Administrated orally. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events | up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) | up to 3 weeks | |
| PK parameter of time of maximum observed concentration (Tmax) | up to 3 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administrated orally. |
|
| PK parameter of area under the concentration time curve (AUC) |
| up to 3 weeks |