Dose Escalation Study of Kylo-0603 in Healthy Subjects

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365580
• Other study ID #: Kylo-0603-I-C01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 23, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Kylonova (Xiamen) Biopharma co., LTD.
• Contact: Qinsheng Zhang
• Phone: +86-021-58217380
• Email: zhangqsh[@]hygieiapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• Kylo-0603 capsule
Administrated orally.
• Placebo
Administrated orally.

Locations

Country	Name	City	State
China	The first affiliated hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Kylonova (Xiamen) Biopharma co., LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events		up to 3 weeks
Secondary	Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)		up to 3 weeks
Secondary	PK parameter of time of maximum observed concentration (Tmax)		up to 3 weeks
Secondary	PK parameter of area under the concentration time curve (AUC)		up to 3 weeks