Nonalcoholic SteatohepatitisPhase 1NCT06365580
Dose Escalation Study of Kylo-0603 in Healthy Subjects
A Phase 1 study testing Kylo-0603 capsule in people with Nonalcoholic Steatohepatitis, run by Kylonova (Xiamen) Biopharma co., LTD. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- Kylo-0603 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2023to 16 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
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
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.
Read the detailed description
The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Kylo-0603 capsule, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kylo-0603 capsuleDrug
Administrated orally.
PlaceboDrug
Administrated orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Kylo-0603 capsule |
| Placebo | Placebo comparator | Subjects will receive matching placebo in part 1, part 2 and part 3. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events
Measured: up to 3 weeks
Secondary outcomes (3)
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Measured: up to 3 weeks
PK parameter of time of maximum observed concentration (Tmax)
Measured: up to 3 weeks
PK parameter of area under the concentration time curve (AUC)
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start23 May 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kylonova (Xiamen) Biopharma co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365580
- Sponsor's protocol ID
- Kylo-0603-I-C01
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06365580
- Acronym / sponsor ID
- Kylo-0603-I-C01
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Kylonova (Xiamen) Biopharma co., LTD.Industry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kylo-0603 | Experimental | Drug: Kylo-0603 capsuleIn 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 comparator | Drug: PlaceboSubjects will receive matching placebo in part 1, part 2 and part 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kylo-0603 capsuleAdministrated orally. | Drug | Kylo-0603 |
| PlaceboAdministrated orally. | Drug | Placebo |
Primary outcome
incidence of adverse events
Time frame: up to 3 weeks
3 secondary outcomes
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Time frame: up to 3 weeks
PK parameter of time of maximum observed concentration (Tmax)
Time frame: up to 3 weeks
PK parameter of area under the concentration time curve (AUC)
Time frame: up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kylo-0603 capsule in people with Nonalcoholic Steatohepatitis, run by Kylonova (Xiamen) Biopharma co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse events (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.