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

Study Overview
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Brief Summary
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This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SLN124
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0mg/kg<br>Drug: SLN124 | Drug: SLN124<br>* SLN124 for subcutaneous (s.c.) injection<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sodium chloride for s.c. injection<br>|
| Experimental: 3.0mg/kg<br>Drug: SLN124 | Drug: SLN124<br>* SLN124 for subcutaneous (s.c.) injection<br>|
| Experimental: Optional Cohort<br>An additional dose level may be explored | Drug: SLN124<br>* SLN124 for subcutaneous (s.c.) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | safety and tolerability | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |