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

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06783881

Enrollment

Registered

2025-01-20

Start date

2025-03-12

Completion date

2026-08-30

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

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.

Interventions

DRUGKylo-12

Administered SC.

DRUGPlacebo

Administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	up to Week 24

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026