Single-ascending Dose Study of Kylo-11 in Healthy Subjects

NCT06363851 | Completed Phase 1

• 1 other identifier: Kylo-11-I-C01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers. Approximately 60 subjects with baseline Lp(a) levels of 75-200 nmol/L are enrolled in the SAD part including dose levels of 9 mg, 30 mg, 75 mg, 225 mg, 450 mg, and 600 mg (Cohort 1-6) to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Kylo-11. Additionally, the dose of 225 mg is further evaluated in healthy participants with baseline Lp(a) level\>200 nmol/L (Cohort 7).

Conditions

Cardiovascular Diseases

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 Lp(a) over time

  up to Week 48

Study Arms (2)

Kylo-11

EXPERIMENTAL

Single ascending doses of Kylo-11 administered subcutaneously (SC).

Drug: Kylo-11

Placebo

PLACEBO COMPARATOR

Administered SC.

Drug: Placebo

Interventions

Kylo-11 DRUG

Administered SC.

Kylo-11

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 Lp(a) level: Lp(a) 75 \~ 200 nmol/L for Cohort 1-6; Lp(a) \>200 nmol/L for Cohort 7;
• 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

Cardiovascular 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: April 9, 2024
• First Posted: April 12, 2024
• Study Start: May 16, 2024
• Primary Completion: June 17, 2025
• Study Completion: December 7, 2025
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)