NCT06783881Active, not recruitingPhase 1
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects
Kylonova (Xiamen) Biopharma co., LTD.2 sites in 1 country50 target enrollmentStarted: March 12, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
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 TG 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.
Arms & Interventions
Kylo-12
Experimental
Single ascending doses of Kylo-12 administered subcutaneously (SC).
Intervention: Kylo-12 (Drug)
Placebo
Placebo Comparator
Administered SC.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: up to Week 24
Secondary Outcomes
- Incidence of adverse events(up to week 48)
- Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)(up to Week 48)
- PK parameter of time of maximum observed concentration (Tmax)(up to Week 48)
- PK parameter of area under the concentration time curve (AUC)(up to Week 48)
- Change in serum ApoC3 and TG over time(up to Week 48)
- Percent change in serum ApoC3 and TG over time(up to Week 48)
Investigators
Study Sites (2)
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