Dose Escalation Study of Kylo-0603 in Healthy Subjects

Phase 1

Completed

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Drug: Kylo-0603 capsule; Drug: Placebo

• Registration Number: NCT06365580
• Lead Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

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).

Study Timeline

• Study Start: 2023-05-23
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Primary Completion: 2024-08-16
• Study Completion: 2024-08-16
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kylo-0603	Kylo-0603 capsule	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.
Placebo	Placebo	Subjects will receive matching placebo in part 1, part 2 and part 3.

Primary Outcome Measures

Name	Time	Method
incidence of adverse events	up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
PK parameter of area under the concentration time curve (AUC)	up to 3 weeks
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

Trial Locations

Locations (1)

The first affiliated hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China