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

NCT ID: NCT04559971

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2021-03-23

Brief Summary

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

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1.0mg/kg

Drug: SLN124

Group Type: EXPERIMENTAL

SLN124

Intervention Type: DRUG

SLN124 for subcutaneous (s.c.) injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sodium chloride for s.c. injection

3.0mg/kg

Drug: SLN124

Group Type: EXPERIMENTAL

SLN124

Intervention Type: DRUG

SLN124 for subcutaneous (s.c.) injection

Optional Cohort

An additional dose level may be explored

Group Type: EXPERIMENTAL

SLN124

Intervention Type: DRUG

SLN124 for subcutaneous (s.c.) injection

Interventions

SLN124

SLN124 for subcutaneous (s.c.) injection

Intervention Type: DRUG

Placebo

Sodium chloride for s.c. injection

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Silence Therapeutics plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giles Campion, MD

Role: STUDY_DIRECTOR

Silence Therapeutics

Locations

Hammersmith Medicines Research

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37497888 (View on PubMed)

Other Identifiers

SLN124-003

Identifier Type: -

Identifier Source: org_study_id