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

Phase 1

Not yet recruiting

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: Kylo-12

• Registration Number: NCT06783881

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Study Start: 2025-02-17
• Primary Completion: 2026-02-17
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered SC.
Kylo-12	Kylo-12	Single ascending doses of Kylo-12 administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	up to Week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chengdu Xinhua Hospital; 🇨🇳 Chengdu, Sichuan, China