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

Last updated: January 15, 2025
Sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Overall Status: Active - Recruiting

Phase

1

Condition

Vascular Diseases

Treatment

Placebo

Kylo-11

Clinical Study ID

NCT06363851
Kylo-11-I-C01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Eligibility Criteria

Inclusion

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;

  • Female subjects must not be able to get pregnant and male subjects must agree toadhere to contraception restrictions;

  • Willing to comply with protocol required visits and assessments, and provide writteninformed consent.

Exclusion

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, humanimmunodeficiency 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 beforedosing;

  • History of stroke or myocardial infarction within 6 months before sceening;

  • Pregnant or breast-feeding women;

  • Other exclusion criteria applied per protocol.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 16, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Chengdu Xinhua Hospital

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

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