Trials Sponsors Conditions Drugs Pricing

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 chlorideDrug: Citrate bufferDrug: MannitolDevice: 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.

Interventions

Sodium chlorideDrug

Administered SC infusion.

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

Citrate bufferDrug

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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)

Sponsors & Collaborators

Eli Lilly and Company
Industrylead

Study Sites (1)

Syneos Health

Québec, G1P 0A2, Canada

MeSH Terms

Interventions

Sodium ChlorideMannitol

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

Study Director
Eli Lilly and Company
STUDY DIRECTOR

Enrollment

44 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Sequence 1 (ABCD)

Sequence 2 (BDAC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Sequence 3 (CADB)

Sequence 4 (DCBA)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Sequence 1 (ABCD)

Sequence 2 (BDAC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Sequence 3 (CADB)

Sequence 4 (DCBA)

You may not qualify if:

Data Sharing

Source record

Locations