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A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers

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: NCT04559971
Recruitment Status : Active, not recruiting
First Posted : September 23, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Silence Therapeutics plc

Brief Summary:
This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: SLN124 Drug: Placebo Early Phase 1

Detailed Description:

This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN124 after single ascending s.c. doses in healthy male and female subjects.

Up to 3 cohorts of 24 healthy volunteers will be enrolled. Each subject will receive a single dose of SLN124 or placebo given by subcutaneous (s.c) injection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SLN124 in Healthy Volunteers
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: 1.0mg/kg
Drug: SLN124
Drug: SLN124
SLN124 for subcutaneous (s.c.) injection

Placebo Comparator: Placebo Drug: Placebo
Sodium chloride for s.c. injection

Experimental: 3.0mg/kg
Drug: SLN124
Drug: SLN124
SLN124 for subcutaneous (s.c.) injection

Experimental: Optional Cohort
An additional dose level may be explored
Drug: SLN124
SLN124 for subcutaneous (s.c.) injection




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 8 weeks ]
    safety and tolerability


Secondary Outcome Measures :
  1. Pharmacokinetic: peak plasma concentration (Cmax) [ Time Frame: 7 days ]
  2. Pharmacokinetic: area under the plasma concentration (AUC) [ Time Frame: 7 days ]
  3. Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F) [ Time Frame: 7 days ]

Other Outcome Measures:
  1. Pharmacodynamic: change in ferritin [ Time Frame: 8 weeks ]
  2. Pharmacodynamic: change in TSAT [ Time Frame: 8 weeks ]
  3. Pharmacodynamic: change in hepcidin [ Time Frame: 8 weeks ]
  4. Pharmacodynamic: change in haemoglobin [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normotensive male or female volunteers, with a body mass index of 18.0-30.0 kg/m2.
  • Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine.
  • Agree to follow the contraception requirements of the trial.
  • Able to give fully informed written consent.
  • Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.

Exclusion Criteria:

  • History or presence of iron deficiency or iron deficiency anaemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions.
  • Positive tests for hepatitis B & C, HIV
  • Drug or alcohol abuse.
  • Smoke more than 10 cigarettes (or equivalent) daily.
  • Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication (with the exception of hormone replacement therapy [HRT]) during the 28 days before first dose of trial medication.
  • Use of supplement(s) during the 28 days before screening.
  • Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months.
  • Clinically relevant abnormal medical history or concurrent medical condition.
  • Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.

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): NCT04559971


Locations
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United Kingdom
Hammersmith Medicines Research
London, United Kingdom
Sponsors and Collaborators
Silence Therapeutics plc
Investigators
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Study Director: Giles Campion, MD Silence Therapeutics
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Responsible Party: Silence Therapeutics plc
ClinicalTrials.gov Identifier: NCT04559971    
Other Study ID Numbers: SLN124-003
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No