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NCT06363851 | Not yet recruiting | Cardiovascular Diseases

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

Kylonova (Xiamen) Biopharma co., LTD.

Brief 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.

Condition or disease

Cardiovascular Diseases

Intervention/treatment

Kylo-11

Placebo

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects
Actual Study Start Date : May 31, 2024
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : November 30, 2025
Arm Intervention/treatment

Experimental: Kylo-11

Single ascending doses of Kylo-11 administered subcutaneously (SC).

Friend: Kilo-11

Placebo Comparator: Placebo

Administered SC.

Drug: Placebo
Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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 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 exclusion criteria applied per protocol.
Single-ascending Dose Study of Kylo-11 in Healthy Subjects

Location Details

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

How to Participate

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Locations

Not yet recruiting

China, Sichuan

ChengduX in hospital

Chengdu, Sichuan, China, 610000