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

• Status: Recruiting
• Trial end date: 2021-12-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mannitol

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