Dose Escalation Study of Kylo-0603 in Healthy Subjects

NCT06365580 | Completed Phase 1

• 1 other identifier: Kylo-0603-I-C01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• incidence of adverse events

  up to 3 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Kylo-0603

EXPERIMENTAL

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.

Drug: Kylo-0603 capsule

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Kylo-0603 capsule DRUG

Administrated orally.

Kylo-0603

Placebo DRUG

Administrated orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

The first affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: May 23, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-04

Locations

CN (1)