HypertriglyceridemiaPhase 1NCT06783881
Single-ascending Dose Study of Kylo-12 in Healthy Subjects
A Phase 1 study testing Kylo-12 in people with Hypertriglyceridemia, run by Kylonova (Xiamen) Biopharma co., LTD. at 1 site in China.
Trial summary
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Kylo-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to 30 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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;
- Protocol-defined elevated serum TG level;
- 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 or evidence of a clinically significant disorder, condition or disease;
- Received an investigational drug, vaccine or device within 3 months before dosing;
- 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 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;
- History of stroke or myocardial infarction within 6 months before sceening;
- Pregnant or breast-feeding women;
- Other exclusion criteria applied per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
- Conditions
- Hypertriglyceridemia
- Being tested
- Kylo-12, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kylo-12Drug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Kylo-12 | Experimental | Single ascending doses of Kylo-12 administered subcutaneously (SC). Receives: Drug: Kylo-12 |
| Placebo | Placebo comparator | Administered SC. 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 Week 24
Secondary outcomes (6)
Incidence of adverse events
Measured: up to week 48
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Measured: up to Week 48
PK parameter of time of maximum observed concentration (Tmax)
Measured: up to Week 48
PK parameter of area under the concentration time curve (AUC)
Measured: up to Week 48
Change in serum ApoC3 and TG over time
Measured: up to Week 48
Percent change in serum ApoC3 and TG over time
Measured: up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start12 Mar 2025
- Primary completion19 Dec 2025
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- 50 participants (estimated)
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
- NCT06783881
- Sponsor's protocol ID
- Kylo-12-I-C01
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. 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, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06783881
- Acronym / sponsor ID
- Kylo-12-I-C01
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kylonova (Xiamen) Biopharma co., LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 20 Jan 2025 (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 is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
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-12 | Experimental | Drug: Kylo-12Single ascending doses of Kylo-12 administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboAdministered SC. |
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;
- Protocol-defined elevated serum TG level;
- 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 (10 listed)
- History or evidence of a clinically significant disorder, condition or disease;
- Received an investigational drug, vaccine or device within 3 months before dosing;
- 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 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-12Administered SC. | Drug | Kylo-12 |
| PlaceboAdministered SC. | Drug | Placebo |
Primary outcome
Incidence of adverse events
Time frame: up to Week 24
6 secondary outcomes
Incidence of adverse events
Time frame: up to week 48
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Time frame: up to Week 48
PK parameter of time of maximum observed concentration (Tmax)
Time frame: up to Week 48
PK parameter of area under the concentration time curve (AUC)
Time frame: up to Week 48
Change in serum ApoC3 and TG over time
Time frame: up to Week 48
Percent change in serum ApoC3 and TG over time
Time frame: up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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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-12 in people with Hypertriglyceridemia, 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 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Week 24). 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 16 Mar 2026.