Single-ascending Dose Study of Kylo-12 in Healthy Subjects

Kylonova (Xiamen) Biopharma co., LTD.

Status and phase: Not yet enrolling; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: Kylo-12; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06783881

Kylo-12-I-C01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Kylo-12

Experimental group

Description:

Single ascending doses of Kylo-12 administered subcutaneously (SC).

Treatment:

Drug: Kylo-12

Placebo

Placebo Comparator group

Description:

Administered SC.

Treatment:

Drug: Placebo