NCT04559971

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P50-P75 for early_phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

September 8, 2020

Last Update Submit

April 20, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events

    safety and tolerability

    8 weeks

Secondary Outcomes (3)

  • 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 Outcomes (4)

  • Pharmacodynamic: change in ferritin

    8 weeks

  • Pharmacodynamic: change in TSAT

    8 weeks

  • Pharmacodynamic: change in hepcidin

    8 weeks

  • +1 more other outcomes

Study Arms (4)

1.0mg/kg

EXPERIMENTAL

Drug: SLN124

Drug: SLN124

Placebo

PLACEBO COMPARATOR
Drug: Placebo

3.0mg/kg

EXPERIMENTAL

Drug: SLN124

Drug: SLN124

Optional Cohort

EXPERIMENTAL

An additional dose level may be explored

Drug: SLN124

Interventions

SLN124DRUG

SLN124 for subcutaneous (s.c.) injection

1.0mg/kg3.0mg/kgOptional Cohort
PlaceboDRUG

Sodium chloride for s.c. injection

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

Related Publications (1)

  • Porter JB, Scrimgeour A, Martinez A, James L, Aleku M, Wilson R, Muckenthaler M, Boyce M, Wilkes D, Schaeper U, Campion GV. SLN124, a GalNAc conjugated 19-mer siRNA targeting tmprss6, reduces plasma iron and increases hepcidin levels of healthy volunteers. Am J Hematol. 2023 Sep;98(9):1425-1435. doi: 10.1002/ajh.27015. Epub 2023 Jul 27.

    PMID: 37497888DERIVED

Study Officials

  • Giles Campion, MD

    Silence Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 23, 2020

Study Start

September 3, 2020

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

GB(1)