Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)

Phase 1

Completed

• Conditions: Hyperlipidemias; Dyslipidemias; Elevated Lp(a)
• Interventions: Drug: SLN360; Drug: Placebo

• Registration Number: NCT04606602
• Lead Sponsor: Silence Therapeutics plc

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 Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Study Start: 2020-11-18
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 mg	SLN360	-
300 mg	SLN360	-
600 mg	SLN360	-
900 mg	SLN360	-
Placebo	Placebo	-
100 mg	SLN360	-
100 mg multi dose	SLN360	-
200 mg multi dose	SLN360	-
300 mg multi dose	SLN360	-
600 mg multi dose	SLN360	-
Placebo multi dose	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	Day 201	safety and tolerability will be reported separately following multiple-dose administration.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic: area under the plasma concentration (AUC)	Day 150 and Day 201	safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Pharmacokinetic: peak plasma concentration (Cmax)	Day 150 and Day 201	safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)	Day 150 and Day 201	safety and tolerability will be reported separately following single-dose and multiple-dose administration.
Pharmacodynamic: Change in Lp(a)	Day 150 and Day 201	safety and tolerability will be reported separately following single-dose and multiple-dose administration.

Trial Locations

Locations (8)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Metabolic and Atherosclerosis Research Center; 🇺🇸 Cincinnati, Ohio, United States

Jacksonville Center for Clinical Research Ltd.; 🇺🇸 Jacksonville, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Linear Clinical Research; 🇦🇺 Perth, Western Australia, Australia

Monash Medical Centre; 🇦🇺 Clayton, Australia

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom

Amsterdam Medical Centre; 🇳🇱 Amsterdam, Netherlands