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

NCT06783881 | Active Not Recruiting Phase 1

• 1 other identifier: Kylo-12-I-C01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  up to Week 24

Secondary Outcomes (6)

• 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

Study Arms (2)

Kylo-12

EXPERIMENTAL

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

Drug: Kylo-12

Placebo

PLACEBO COMPARATOR

Administered SC.

Drug: Placebo

Interventions

Kylo-12 DRUG

Administered SC.

Kylo-12

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kylonova (Xiamen) Biopharma co., LTD.: lead

Study Sites (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: March 12, 2025
• Primary Completion: December 19, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)