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Purpose

This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 to 80 years - Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a) - Other inclusion criteria applied per protocol.

Exclusion Criteria

  • Have moderate to severe heart failure (New York Heart Association [NYHA] Functional Classification III or IV during Screening) or last known left ventricular ejection fraction <30% - Have uncontrolled hypertension (systolic blood pressure [SBP] ≥160 mmHg or diastolic blood pressure [DBP] ≥100 mmHg) - Have uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization - Have had any malignancy within 5 years prior to randomization (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma that has been successfully treated) - Other exclusion criteria applied per protocol.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Kylo-11 dose 1 or matched placebo will be administered subcutaneously
  • Drug: Kylo-11 or matched placebo
    Administered subcutaneously
Experimental
Cohort 2 		Kylo-11 dose 2 or matched placebo will be administered subcutaneously
  • Drug: Kylo-11 or matched placebo
    Administered subcutaneously
Experimental
Cohort 3 		Kylo-11 dose 3 or matched placebo will be administered subcutaneously
  • Drug: Kylo-11 or matched placebo
    Administered subcutaneously

Recruiting Locations

Clinical Research of West Florida (CRWF) - Clearwater
Clearwater, Florida 33765
Contact:
Leonard Dunn

Family Research and Healthcare Center Inc.
Doral, Florida 33126
Contact:
Tomas Iglesias

Family Research Centers - Hialeah
Hialeah, Florida 33012
Contact:
Tomas Iglesias

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Contact:
Michael J Koren

Clinical Research of West Florida (CRWF) - Tampa
Tampa, Florida 33606
Contact:
Lon Lynn

Centricity Research d/b/a Lucas Research, Inc.
Morehead City, North Carolina 28557
Contact:
Kathryn Lucas

More Details

Status
Recruiting
Sponsor
Kylonova (Xiamen) Biopharma co., LTD.

Study Contact

Qinsheng Zhang
+86-18936916318
zhangqsh@hygieiapharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.