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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04606602
Recruitment Status : Active, not recruiting
First Posted : October 28, 2020
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Silence Therapeutics plc

Study Description
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Brief Summary:
This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).

Condition or disease Intervention/treatment Phase
Hyperlipidemias Dyslipidemias Elevated Lp(a) Drug: SLN360 Drug: Placebo Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: 30 mg Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Placebo Comparator: Placebo Drug: Placebo
Sodium chloride for subcutaneous (s.c.) injection
Experimental: 100 mg Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 300 mg Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 600 mg Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 900 mg Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 100 mg multi dose Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 200 mg multi dose Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 300 mg multi dose Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Experimental: 600 mg multi dose Drug: SLN360
SLN360 for subcutaneous (s.c.) injection
Placebo Comparator: Placebo multi dose Drug: Placebo
Sodium chloride for subcutaneous (s.c.) injection


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Day 150 ]
    safety and tolerability will be reported separately following single-dose administration.

  2. Incidence of treatment-emergent adverse events [ Time Frame: Day 201 ]
    safety and tolerability will be reported separately following multiple-dose administration.


Secondary Outcome Measures :
  1. Pharmacokinetic: peak plasma concentration (Cmax) [ Time Frame: Day 150 and Day 201 ]
    safety and tolerability will be reported separately following single-dose and multiple-dose administration.

  2. Pharmacokinetic: area under the plasma concentration (AUC) [ Time Frame: Day 150 and Day 201 ]
    safety and tolerability will be reported separately following single-dose and multiple-dose administration.

  3. Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F) [ Time Frame: Day 150 and Day 201 ]
    safety and tolerability will be reported separately following single-dose and multiple-dose administration.

  4. Pharmacodynamic: Change in Lp(a) [ Time Frame: Day 150 and Day 201 ]
    safety and tolerability will be reported separately following single-dose and multiple-dose administration.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Elevated plasma Lp(a) ≥ 150nmol/L.
  • All subjects must agree to adhere to appropriate contraception requirements.
  • Subjects must provide written informed consent and be able to comply with all study requirements.
  • Body mass index of ≥ 18 kg/m2 and ≤ 45 kg/m2.
  • For the MD part: confirmed history of stable atherosclerortic cardiovascular disease.

Exclusion criteria:

  • Single Ascending Dose only: any history of clinically overt cardiovascular disease, defined as acute coronary syndromes, myocardial infarction, stable angina, coronary or other revascularization, ischemic stroke or transient ischemic attack and atherosclerotic peripheral arterial disease.
  • Multiple Dose only: recent history of acute cardiovascular disease events within 6 months of screening (including, but not limited to, acute myocardial infarction, unstable angina, acute stroke and acute limb ischemia).
  • Moderate or severe hepatic cirrhosis with Child-Pugh grade B or C, or other current or previous liver disease.
  • Active serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention.
  • Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrolment in the study or could interfere with the subject's participation in, or completion of the study.
  • Subjects with previous or current use of medication or therapies significantly affecting Lp(a) level or hormone replacement therapy, unless on a stable dose for ≥ 8 weeks prior to screening
  • History or clinical evidence of alcohol or illegal drug misuse within the 6 months before screening.
  • History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc, or intolerance to s.c. injections.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606602


Locations
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United States, Florida
Jacksonville Center for Clinical Research Ltd.
Jacksonville, Florida, United States, 32216
Progressive Medical Research
Port Orange, Florida, United States, 32127
United States, Ohio
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45227
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Australia, Western Australia
Linear Clinical Research
Perth, Western Australia, Australia
Australia
Monash Medical Centre
Clayton, Australia
Netherlands
Amsterdam Medical Centre
Amsterdam, Netherlands
United Kingdom
Hammersmith Medicines Research
London, United Kingdom
Sponsors and Collaborators
Silence Therapeutics plc
Medpace, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Silence Therapeutics plc
ClinicalTrials.gov Identifier: NCT04606602    
Other Study ID Numbers: SLN360-001
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silence Therapeutics plc:
Dyslipidemia, Dyslipoproteinemia, Hyperlipidemia, Hyperlipoproteinemia, Hyperlipoproteinemia (a), Lipoprotein, Lipoprotein (a)
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases