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Clinical trial No longer in our active list Phase 1 Interventional Ages 18 to 55

Testing Kylo-11 in healthy volunteers

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

Run by Kylonova (Xiamen) Biopharma co., LTD. · NCT06363851 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new drug called Kylo-11 in healthy volunteers to see if it's safe and how it works, which could help in treating heart diseases in the future.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment60 (estimated)
SponsorKylonova (Xiamen) Biopharma co., LTD.
Industry-sponsored
Locations1 site (Chengdu, Sichuan)
Trial IDNCT06363851 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy men and women aged 18 to 55 with a specific elevated serum Lp(a) level.

Probably not a fit

Patients with significant medical disorders or those who have recently participated in other clinical trials may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, randomized, double-blind, placebo-controlled study evaluating Kylo-11 in approximately 60 healthy subjects. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of Kylo-11 through a single ascending dose approach. Participants will be monitored for their responses to the drug compared to a placebo. The study is designed to gather essential data that could inform future research on Kylo-11's potential applications in treating cardiovascular diseases.

Why it matters

Potential benefit: If successful, this study could lead to new insights into the safety and effects of Kylo-11, potentially paving the way for future treatments for cardiovascular diseases.

How similar studies have gone: While this is a first-in-human study, similar approaches in early-phase trials have shown promise in evaluating new treatments for cardiovascular conditions.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Chengdu Xinhua Hospital
    Chengdu, Sichuan, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.