Trials / Completed
CompletedNCT04606602
Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Silence Therapeutics plc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SLN360 | SLN360 for subcutaneous (s.c.) injection |
| DRUG | Placebo | Sodium chloride for subcutaneous (s.c.) injection |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2023-08-23
- Completion
- 2023-08-23
- First posted
- 2020-10-28
- Last updated
- 2024-08-12
Locations
8 sites across 4 countries: United States, Australia, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04606602. Inclusion in this directory is not an endorsement.