Cardiovascular Diseases
Conditions
Brief summary
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).
Interventions
DRUGKylo-11
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
Kylonova (Xiamen) Biopharma co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women aged 18 to 55 years old, inclusive; * Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive; * Protocol-defined elevated serum Lp(a) level: Lp(a) 75 \~ 200 nmol/L for Cohort 1-6; Lp(a) \>200 nmol/L for Cohort 7; * Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions; * Willing to comply with protocol required visits and assessments, and provide written informed consent.
Exclusion criteria
* History or evidence of a clinically significant disorder, condition or disease; * Received an investigational drug, vaccine or device within 3 months before dosing; * History of evidence of malignant tumor or Gilbert syndrome; * Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection; * History of alcohol abuse within 12 months before dosing; * History of drug abuse within 3 months before screening; * History of blood donations or blood loss of 400 ml and more within 3 months before dosing; * History of stroke or myocardial infarction within 6 months before sceening; * Pregnant or breast-feeding women; * Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | up to Week 24 |
Secondary
| Measure | 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) | 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 |
Countries
China
Outcome results
None listed