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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559971
• Other study ID #: SLN124-003
• Status: Completed
• Phase: Early Phase 1
• Start date: September 3, 2020
• Est. completion date: March 23, 2021

Study information

• Verified date: April 2023
• Source: Silence Therapeutics plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SLN124
SLN124 for subcutaneous (s.c.) injection
• Placebo
Sodium chloride for s.c. injection

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Silence Therapeutics plc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacodynamic: change in ferritin		8 weeks
Other	Pharmacodynamic: change in TSAT		8 weeks
Other	Pharmacodynamic: change in hepcidin		8 weeks
Other	Pharmacodynamic: change in haemoglobin		8 weeks
Primary	Incidence of treatment-emergent adverse events	safety and tolerability	8 weeks
Secondary	Pharmacokinetic: peak plasma concentration (Cmax)		7 days
Secondary	Pharmacokinetic: area under the plasma concentration (AUC)		7 days
Secondary	Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)		7 days