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NCT Number: NCT06363851

Single-ascending Dose Study 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).

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chengdu Xinhua Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kylo-11

Drug

Administered SC.

Placebo

Drug

Administered SC.

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

Sponsors and collaborators

Lead sponsor

Kylonova (Xiamen) Biopharma co., LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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