Dose Escalation Study of Kylo-0603 in Healthy Subjects

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of Kylo-0603 Capsules in Healthy Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Kylo-0603 capsule; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qinsheng Zhang; Phone Number: +86-021-58217380; Email: zhangqsh@hygieiapharma.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kylo-0603; In part 1, subjects will receive single dose Kylo-0603 orally at dose levels of 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, 4.6 mg, 8.6 mg, 12 mg and 16 mg on Day 1. In part 2, subjects will receive Kylo-0603 4.6 mg on Day 1 in fasted state and on Day 4 after a standard high-fat meal. In part 3, subject will receive Kylo-0603 orally once daily for 14 days at dose levels of 1.2 mg, 2 mg, 4 mg, 8 mg, 12 mg, and 16 mg.	Drug: Kylo-0603 capsule; Administrated orally.
Placebo Comparator: Placebo; Subjects will receive matching placebo in part 1, part 2 and part 3.	Drug: Placebo; Administrated orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of adverse events	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)	up to 3 weeks
PK parameter of time of maximum observed concentration (Tmax)	up to 3 weeks
PK parameter of area under the concentration time curve (AUC)	up to 3 weeks

Collaborators and Investigators

• Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Kylo-0603-I-C01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No