Dose Escalation Study of Kylo-0603 in Healthy Subjects

Last updated: October 7, 2024
Sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Overall Status: Completed

Phase

1

Condition

Liver Disease

Treatment

Placebo

Kylo-0603 capsule

Clinical Study ID

NCT06365580
Kylo-0603-I-C01
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.

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;

  • Having no clinically significant disorder, condition or disease at screening andbefore first dosing;

  • 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 of cardiovascular, respiratory, digestive, liver, urinary, hematological,endocrine, metabolic, immune, cutaneous, or psychoneurotic diseases;

  • 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 tuberculosis 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;

  • Pregnant or breast-feeding women;

  • Other exclusion criteria applied per protocol.

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 23, 2023
Estimated Completion Date:
August 16, 2024

Study Description

The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).

Connect with a study center

  • The first affiliated hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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