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Dose Escalation Study of Kylo-0603 in Healthy Subjects

Recruiting
18 - 55 years of age
Both
Phase 1

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Overview

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.

Description

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

Eligibility

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 and before first dosing;
  • 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 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, human immunodeficiency 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 before dosing;
  • Pregnant or breast-feeding women;
  • Other exclusion criteria applied per protocol.

Study details

Nonalcoholic Steatohepatitis

NCT06365580

Kylonova (Xiamen) Biopharma co., LTD.

2 May 2024

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