Testing Kylo-11 in healthy volunteers
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Kylonova (Xiamen) Biopharma co., LTD. Industry-sponsored |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06363851 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18 to 55 with a specific elevated serum Lp(a) level.
Not a fit: Patients with significant medical disorders or those who have recently participated in other clinical trials may not benefit from this study.
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 performed: While this is a first-in-human study, similar approaches in early-phase trials have shown promise in evaluating new treatments for cardiovascular conditions.
Eligibility criteria
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 this trial is running
Chengdu, Sichuan
- Chengdu Xinhua Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Qinsheng Zhang
- Email: zhangqsh@hygieiapharma.com
- Phone: +86-021-58217380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.