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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06365580

Enrollment

132

Registered

2024-04-15

Start date

2023-05-23

Completion date

2024-08-16

Last updated

2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Steatohepatitis

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).

Interventions

DRUGKylo-0603 capsule

Administrated orally.

DRUGPlacebo

Administrated orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
incidence of adverse events	up to 3 weeks

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026