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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Citrate buffer; Device: Prefilled Autoinjector; Drug: Mannitol; Drug: Sodium chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT05154968

18167

J3G-MC-S003 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 4 patient groups

Sequence 1 (ABCD)

Experimental group

Description:

Participants will receive 1 millilitre (ml) subcutaneous (SC) injection of treatment A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at the potential of hydrogen (pH) 5.7) followed by treatments B (higher pain Room Temperature \[RT\] solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), C (lower pain refrigerated solution contains mannitol), and D (lower pain RT solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device.

Treatment:

Drug: Sodium chloride

Drug: Citrate buffer

Drug: Mannitol

Device: Prefilled Autoinjector

Sequence 2 (BDAC)

Experimental group

Description:

Participants will receive 1 ml SC injection of treatment B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) followed by treatments D (lower pain RT solution contains mannitol), A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), and C (lower pain refrigerated solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device.

Treatment:

Drug: Sodium chloride

Drug: Citrate buffer

Drug: Mannitol

Device: Prefilled Autoinjector

Sequence 3 (CADB)

Experimental group

Description:

Participants will receive 1 ml SC injection of treatment C (lower pain refrigerated solution contains mannitol) followed by treatments A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), D (lower pain RT solution contains mannitol), and B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device.

Treatment:

Drug: Sodium chloride

Drug: Citrate buffer

Drug: Mannitol

Device: Prefilled Autoinjector

Sequence 4 (DCBA)

Experimental group

Description:

Participants will receive 1 ml SC injection of treatment D (lower pain RT solution contains mannitol) followed by treatments C (lower pain refrigerated solution contains mannitol), B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), and A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device.

Treatment:

Drug: Sodium chloride

Drug: Citrate buffer

Drug: Mannitol

Device: Prefilled Autoinjector