NCT06363851CompletedPhase 1
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects
Kylonova (Xiamen) Biopharma co., LTD.1 site in 1 country71 target enrollmentStarted: May 16, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers. Approximately 60 subjects with baseline Lp(a) levels of 75-200 nmol/L are enrolled in the SAD part including dose levels of 9 mg, 30 mg, 75 mg, 225 mg, 450 mg, and 600 mg (Cohort 1-6) to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Kylo-11. Additionally, the dose of 225 mg is further evaluated in healthy participants with baseline Lp(a) level>200 nmol/L (Cohort 7).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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: Lp(a) 75 ~ 200 nmol/L for Cohort 1-6; Lp(a) >200 nmol/L for Cohort 7;
- •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.
Arms & Interventions
Placebo
Placebo Comparator
Administered SC.
Intervention: Placebo (Drug)
Kylo-11
Experimental
Single ascending doses of Kylo-11 administered subcutaneously (SC).
Intervention: Kylo-11 (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: up to Week 24
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
Loading locations...
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