Single-ascending Dose Study of Kylo-11 in Healthy Subjects
NCT ID: NCT06363851
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2024-05-16
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Kylo-11
Single ascending doses of Kylo-11 administered subcutaneously (SC).
Kylo-11
Administered SC.
Placebo
Administered SC.
Placebo
Administered SC.
Interventions
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Kylo-11
Administered SC.
Placebo
Administered SC.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
55 Years
ALL
Yes
Sponsors
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Kylonova (Xiamen) Biopharma co., LTD.
INDUSTRY
Responsible Party
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Locations
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Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Countries
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Other Identifiers
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Kylo-11-I-C01
Identifier Type: -
Identifier Source: org_study_id
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