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This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kylo-12 | Experimental | Single ascending doses of Kylo-12 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kylo-12 | Drug | Administered SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | up to week 48 | |
| Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) | up to Week 48 | |
| PK parameter of time of maximum observed concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Drug |
Administered SC. |
|
| up to Week 48 |
| PK parameter of area under the concentration time curve (AUC) | up to Week 48 |
| Change in serum ApoC3 and TG over time | up to Week 48 |
| Percent change in serum ApoC3 and TG over time | up to Week 48 |
| D009750 |
| Nutritional and Metabolic Diseases |