A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Study to Evaluate Injection-Site Pain of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154968
• Other study ID #: 18167
• Secondary ID: J3G-MC-S003
• Status: Completed
• Phase: Phase 1
• Start date: November 24, 2021
• Est. completion date: December 14, 2021

Study information

• Verified date: January 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 14, 2021
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Sodium chloride
Administered SC infusion.
• Citrate buffer
Administered SC infusion.
• Mannitol
Administered SC infusion.

Device:
• Prefilled Autoinjector
Used to administer the drug through SC infusion.

Locations

Country	Name	City	State
Canada	Syneos Health	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	within 1 minute post injection
Secondary	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).	within 5, 10, 15, 30 and 60 minutes post injection
Secondary	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.	10 and 60 minutes post injection