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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SLN124; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Hammersmith Medicines Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Sodium chloride for s.c. injection
Experimental: 1.0mg/kg; Drug: SLN124	Drug: SLN124; SLN124 for subcutaneous (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events	safety and tolerability	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic: peak plasma concentration (Cmax)	7 days
Pharmacokinetic: area under the plasma concentration (AUC)	7 days
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)	7 days

Other Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamic: change in ferritin	8 weeks
Pharmacodynamic: change in TSAT	8 weeks
Pharmacodynamic: change in hepcidin	8 weeks
Pharmacodynamic: change in haemoglobin	8 weeks

Collaborators and Investigators

• Sponsor: Silence Therapeutics plc
• Investigators: Study Director: Giles Campion, MD, Silence Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): March 23, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SLN124-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No