NCT06365580CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 9 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 132 (actual)
- First submitted
- 10 Apr 2024
- Start date
- 23 May 2023
- Primary completion date
- 16 Aug 2024
- Lead sponsor
- Kylonova (Xiamen) Biopharma co., LTD.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06365580
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 132
- From 23 May 2023 to the primary completion date, 16 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Other
- Pregnant or breast-feeding women;
- Other exclusion criteria applied per protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.