Clinical trial NCT04559971: A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Silence Therapeutics plc
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Pharmacokinetic: peak plasma concentration (Cmax)
timeFrame: 7 days
measure: Pharmacokinetic: area under the plasma concentration (AUC)
timeFrame: 7 days
measure: Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)
timeFrame: 7 days
Other outcomes:
measure: Pharmacodynamic: change in ferritin
timeFrame: 8 weeks
measure: Pharmacodynamic: change in TSAT
timeFrame: 8 weeks
measure: Pharmacodynamic: change in hepcidin
timeFrame: 8 weeks
measure: Pharmacodynamic: change in haemoglobin
timeFrame: 8 weeks
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Silence Therapeutics
name: Giles Campion, MD
role: STUDY_DIRECTOR
References: