Single-ascending Dose Study of Kylo-11 in Healthy Subjects

Cardiovascular Diseases Clinical Trial

Official title:

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363851
• Other study ID #: Kylo-11-I-C01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 31, 2024
• Est. completion date: November 30, 2025

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 is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2025
• Est. primary completion date: May 31, 2025
• 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;
• Protocol-defined elevated serum Lp(a) 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.

Exclusion Criteria:

• 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;
• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Kylo-11
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
China	Chengdu Xinhua Hospital	Chengdu	Sichuan

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 Week 24
Secondary	Incidence of adverse events		up to week 48
Secondary	Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)		up to Week 48
Secondary	PK parameter of time of maximum observed concentration (Tmax)		up to Week 48
Secondary	PK parameter of area under the concentration time curve (AUC)		up to Week 48
Secondary	Change in serum Lp(a) over time		up to Week 48
Secondary	Percent change in serum Lp(a) over time		up to Week 48