drugset / Trial / NCT06363851
Single-ascending Dose Study of Kylo-11 in Healthy Subjects
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2024-05-16
- Primary completion
- 2025-06-17
- Completion
- 2025-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Kylo-11 | Unknown | 9 mg | Subcutaneous |
| Subject | Kylo-11 | Unknown | 30 mg | Subcutaneous |
| Subject | Kylo-11 | Unknown | 75 mg | Subcutaneous |
| Subject | Kylo-11 | Unknown | 225 mg | Subcutaneous |
| Subject | Kylo-11 | Unknown | 450 mg | Subcutaneous |
| Subject | Kylo-11 | Unknown | 600 mg | Subcutaneous |