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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04559971

Enrollment

Registered

2020-09-23

Start date

2020-09-03

Completion date

2021-03-23

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGPlacebo

Sodium chloride for s.c. injection

DRUGSLN124

SLN124 for subcutaneous (s.c.) injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026