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Single-ascending Dose Study of Kylo-11 in Healthy Subjects
Sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Summary
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers. Approximately 60 subjects with baseline Lp(a) levels of 75-200 nmol/L are enrolled in the SAD part including dose levels of 9 mg, 30 mg, 75 mg, 225 mg, 450 mg, and 600 mg (Cohort 1-6) to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Kylo-11. Additionally, the dose of 225 mg is further evaluated in healthy participants with baseline Lp(a) level\>200 nmol/L (Cohort 7).
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2024-05-16
Completion Date
2025-12-07
Last Updated
2026-06-26
Healthy Volunteers
Yes
Conditions
Interventions
Kylo-11
Administered SC.
Placebo
Administered SC.
Locations (1)
Chengdu Xinhua Hospital
Chengdu, Sichuan, China