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

NCT05154968 | Completed Phase 1 DMC

• 2 other identifiers: 18167J3G-MC-S003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual analogue scale (VAS) Pain score at Injection Site after Time Zero (T0)

  within 5, 10, 15, 30 and 60 minutes post injection

• Number of Participants with Injection Site Reactions (ISR)

  10 and 60 minutes post injection

Study Arms (4)

Sequence 1 (ABCD)

EXPERIMENTAL

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.

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

Sequence 2 (BDAC)

EXPERIMENTAL

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.

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

Sequence 3 (CADB)

EXPERIMENTAL

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.

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

Sequence 4 (DCBA)

EXPERIMENTAL

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.

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

Interventions

Sodium chloride DRUG

Administered SC infusion.

Sequence 1 (ABCD); Sequence 2 (BDAC); Sequence 3 (CADB); Sequence 4 (DCBA)

Citrate buffer DRUG

Administered SC infusion.

Sequence 1 (ABCD); Sequence 2 (BDAC); Sequence 3 (CADB); Sequence 4 (DCBA)

Mannitol DRUG

Administered SC infusion.

Sequence 1 (ABCD); Sequence 2 (BDAC); Sequence 3 (CADB); Sequence 4 (DCBA)

Prefilled Autoinjector DEVICE

Used to administer the drug through SC infusion.

Sequence 1 (ABCD); Sequence 2 (BDAC); Sequence 3 (CADB); Sequence 4 (DCBA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Syneos Health

Québec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

Sodium Chloride; Mannitol

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Study Director

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Partially blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 13, 2021
• Study Start: November 24, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)