Dose Escalation Study of Kylo-0603 in Healthy Subjects

NCT ID: NCT06365580

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2024-08-16

Brief 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.

Detailed Description

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

Conditions

Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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, 16 mg and 20 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.

Group Type: EXPERIMENTAL

Kylo-0603 capsule

Intervention Type: DRUG

Administrated orally.

Placebo

Subjects will receive matching placebo in part 1, part 2 and part 3.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administrated orally.

Interventions

Kylo-0603 capsule

Administrated orally.

Intervention Type: DRUG

Placebo

Administrated orally.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kylonova (Xiamen) Biopharma co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Kylo-0603-I-C01

Identifier Type: -

Identifier Source: org_study_id