Clinical trial NCT05154968: A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants
Official title: A Study to Evaluate Injection-Site Pain of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Non-smoker
* BMI greater than (\>)18.5 and less than (\<) 30.0 kilograms per square meter (kg/m2)
* Body weight greater than or equal to (≥) 50.0 kg for males and ≥45.0 kg for females
* Are in good health, as determined by the investigator (or designee) to have no clinically significant findings from medical and surgical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations
* Are reliable and willing to make themselves available for the duration of the study, are willing to follow study procedures, and demonstrate the ability to self-inject

Exclusion Criteria:

* Are pregnant or breastfeeding
* Have a positive urine drug screen or alcohol breath test at screening Have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing or concomitant participation in an investigational study involving no drug or device administration
* Have known allergic reactions to any components of mannitol or the placebo matrix or related compounds or history of significant atopy
* Have self-perceived dullness or loss of sensation on either side of the body or the abdomen
* Have tattoos or scars over the abdomen or other factors (e.g., rash, excessive folds of skin) that, in the Investigator's opinion, would interfere with injection site assessments
* Are currently using painkillers, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). Intend to use prescription or over-the-counter medication for pain or inflammation within 7 days prior to the first injection
* Have any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study

Primary outcomes:
measure: Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0)
timeFrame: within 1 minute post injection
Secondary outcomes:
measure: Visual analogue scale (VAS) Pain score at Injection Site after Time Zero (T0)
timeFrame: within 5, 10, 15, 30 and 60 minutes post injection
measure: Number of Participants with Injection Site Reactions (ISR)
timeFrame: 10 and 60 minutes post injection
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Syneos Health
Study officials:
affiliation: Eli Lilly and Company
name: Study Director
role: STUDY_DIRECTOR
References: