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Completed

NCT Number: NCT05154968

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Syneos Health

Québec, G1P 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Chloride

Drug

Administered SC infusion.

Citrate buffer

Drug

Administered SC infusion.

Mannitol

Drug

Administered SC infusion.

Prefilled Autoinjector

Device

Used to administer the drug through SC infusion.

Primary outcomes

  1. Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0)

    Time frame: within 1 minute post injection

    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).

Secondary outcomes

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

    Time frame: within 5, 10, 15, 30 and 60 minutes post injection

    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).

  2. Number of Participants with Injection Site Reactions (ISR)

    Time frame: 10 and 60 minutes post injection

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2021
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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