Single-ascending Dose Study of Kylo-11 in Healthy Subjects
- Registration Number
- NCT06363851
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered SC. Kylo-11 Kylo-11 Single ascending doses of Kylo-11 administered subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Incidence of adverse events up to Week 24
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) up to Week 48 Incidence of adverse events up to week 48 Percent change in serum Lp(a) over time up to Week 48 PK parameter of area under the concentration time curve (AUC) up to Week 48 Change in serum Lp(a) over time up to Week 48 PK parameter of time of maximum observed concentration (Tmax) up to Week 48
Trial Locations
- Locations (1)
Chengdu Xinhua Hospital
🇨🇳Chengdu, Sichuan, China