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

Silence Therapeutics plc (Industry)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Actual Enrollment :
24 participants
Intervention Model:
Parallel Assignment
Double (Participant, Investigator)
Primary Purpose:
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 :
Sep 3, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events [8 weeks]

    safety and tolerability

Secondary Outcome Measures

  1. Pharmacokinetic: peak plasma concentration (Cmax) [7 days]

  2. Pharmacokinetic: area under the plasma concentration (AUC) [7 days]

  3. Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F) [7 days]

Other Outcome Measures

  1. Pharmacodynamic: change in ferritin [8 weeks]

  2. Pharmacodynamic: change in TSAT [8 weeks]

  3. Pharmacodynamic: change in hepcidin [8 weeks]

  4. Pharmacodynamic: change in haemoglobin [8 weeks]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Hammersmith Medicines Research London United Kingdom

Sponsors and Collaborators

  • Silence Therapeutics plc


  • Study Director: Giles Campion, MD, Silence Therapeutics

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Silence Therapeutics plc
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • SLN124-003
First Posted:
Sep 23, 2020
Last Update Posted:
Mar 5, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 5, 2021