NCT04559971CompletedEarly Phase 1
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
Silence Therapeutics plc1 site in 1 country24 target enrollmentStarted: September 3, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Silence Therapeutics plc
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-emergent adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normotensive male or female volunteers, with a body mass index of 18.0-30.0 kg/m
- •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.
Arms & Interventions
1.0mg/kg
Experimental
Drug: SLN124
Intervention: SLN124 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
3.0mg/kg
Experimental
Drug: SLN124
Intervention: SLN124 (Drug)
Optional Cohort
Experimental
An additional dose level may be explored
Intervention: SLN124 (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events
Time Frame: 8 weeks
safety and tolerability
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
Loading locations...
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