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This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers. Approximately 60 subjects with baseline Lp(a) levels of 75-200 nmol/L are enrolled in the SAD part including dose levels of 9 mg, 30 mg, 75 mg, 225 mg, 450 mg, and 600 mg (Cohort 1-6) to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Kylo-11. Additionally, the dose of 225 mg is further evaluated in healthy participants with baseline Lp(a) level>200 nmol/L (Cohort 7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kylo-11 | Experimental | Single ascending doses of Kylo-11 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kylo-11 | 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 |
|---|---|
| D002318 | Cardiovascular 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 Lp(a) over time | up to Week 48 |
| Percent change in serum Lp(a) over time | up to Week 48 |