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CompletedNCT06363851Updated Jun 26, 2026

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

A Phase 1 interventional study of Kylo-11 and Placebo in Cardiovascular Diseases, sponsored by Kylonova (Xiamen) Biopharma co., LTD.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Kylonova (Xiamen) Biopharma co., LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 71 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Kylonova (Xiamen) Biopharma co., LTD. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Kylo-11

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

    Drug: Kylo-11

  • Placebo comparator
    Placebo

    Administered SC.

    Drug: Placebo

Interventions

  • DrugKylo-11

    Administered SC.

  • DrugPlacebo

    Administered SC.

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

    Time frame: up to Week 24

Secondary outcomes

  1. Incidence of adverse events

    Time frame: up to week 48

  2. Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)

    Time frame: up to Week 48

  3. PK parameter of time of maximum observed concentration (Tmax)

    Time frame: up to Week 48

  4. PK parameter of area under the concentration time curve (AUC)

    Time frame: up to Week 48

  5. Change in serum Lp(a) over time

    Time frame: up to Week 48

  6. Percent change in serum Lp(a) over time

    Time frame: up to Week 48

07

Study locations

1 site
  • Chengdu Xinhua Hospital
    Chengdu, Sichuan 610000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06363851
Lead sponsor
Kylonova (Xiamen) Biopharma co., LTD.
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
May 16, 2024
Primary completion
Jun 17, 2025
Completion
Dec 7, 2025
Last update
Jun 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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