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

June 23, 2026 updated by: Kylonova (Xiamen) Biopharma co., LTD.

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Chengdu Xinhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kylo-11
Single ascending doses of Kylo-11 administered subcutaneously (SC).
Drug: Kylo-11
Administered SC.
Placebo Comparator: Placebo
Administered SC.
Drug: Placebo
Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to Week 24
up to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to week 48
up to week 48
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Time Frame: up to Week 48
up to Week 48
PK parameter of time of maximum observed concentration (Tmax)
Time Frame: up to Week 48
up to Week 48
PK parameter of area under the concentration time curve (AUC)
Time Frame: up to Week 48
up to Week 48
Change in serum Lp(a) over time
Time Frame: up to Week 48
up to Week 48
Percent change in serum Lp(a) over time
Time Frame: up to Week 48
up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kylonova (Xiamen) Biopharma co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2024

Primary Completion (Actual)

June 17, 2025

Study Completion (Actual)

December 7, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kylo-11-I-C01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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