The main purpose of the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Syneos Health
Québec, Canada
Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0)
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst possible pain).
Time frame: within 1 minute post injection
Visual analogue scale (VAS) Pain score at Injection Site after Time Zero (T0)
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst possible pain).
Time frame: within 5, 10, 15, 30 and 60 minutes post injection
Number of Participants with Injection Site Reactions (ISR)
ISR will consists of rating the severity of skin reaction at the injection site using the scores below 0=no reaction, 1= easily tolerated erythema and/or light bruising, 2= distributing erythema with swelling and/or distributing bruising, 3=almost intolerable symptoms, or clinically definite skin necrosis, characterized by any of the following: oozing, weeping, skin breakdown, ulceration, scar formation. Higher the score worst the injection site reaction.
Time frame: 10 and 60 minutes post injection
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Used to administer the drug through SC infusion.