Single-ascending Dose Study of Kylo-11 in Healthy Subjects

Phase

Condition

Vascular Diseases

Treatment

Kylo-11

Placebo

Clinical Study ID

NCT06363851

Kylo-11-I-C01

Ages 18-55
All Genders
Accepts Healthy Volunteers

Study Summary

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Eligibility Criteria

Inclusion

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;
Female subjects must not be able to get pregnant and male subjects must agree toadhere to contraception restrictions;
Willing to comply with protocol required visits and assessments, and provide writteninformed consent.

Exclusion

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, humanimmunodeficiency 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 beforedosing;
History of stroke or myocardial infarction within 6 months before sceening;
Pregnant or breast-feeding women;
Other exclusion criteria applied per protocol.

Study Design