A Randomised, Double-blind, Placebo Controlled, First-in-human Study to Investigate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of SLN360 in Subjects With Elevated Lipoprotein(a)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Silence Therapeutics plc
- Enrollment
- 70
- Locations
- 8
- Primary Endpoint
- Incidence of treatment-emergent adverse events
Study Overview
Brief Summary
This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).
Detailed Description
This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN360 after single ascending s.c. doses and multiple doses in healthy male and female subjects.
Up to 9 cohorts of 88 patients with elevated Lp(a) will be enrolled. Each patient will receive single or multiple doses of SLN360 or placebo given by subcutaneous (s.c) injection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
30 mg
Intervention: SLN360 (Drug)
Placebo
Intervention: Placebo (Drug)
100 mg
Intervention: SLN360 (Drug)
300 mg
Intervention: SLN360 (Drug)
600 mg
Intervention: SLN360 (Drug)
900 mg
Intervention: SLN360 (Drug)
100 mg multi dose
Intervention: SLN360 (Drug)
200 mg multi dose
Intervention: SLN360 (Drug)
300 mg multi dose
Intervention: SLN360 (Drug)
600 mg multi dose
Intervention: SLN360 (Drug)
Placebo multi dose
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events
Time Frame: Day 201
safety and tolerability will be reported separately following multiple-dose administration.
Secondary Outcomes
- Pharmacokinetic: area under the plasma concentration (AUC)(Day 150 and Day 201)
- Pharmacokinetic: peak plasma concentration (Cmax)(Day 150 and Day 201)
- Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)(Day 150 and Day 201)
- Pharmacodynamic: Change in Lp(a)(Day 150 and Day 201)