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

NCT05154968 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-01-13

No results posted yet for this study

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

Interventions

DRUG

Sodium chloride

Administered SC infusion.

DRUG

Citrate buffer

Administered SC infusion.

DRUG

Mannitol

Administered SC infusion.

DEVICE

Prefilled Autoinjector

Used to administer the drug through SC infusion.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154968 on ClinicalTrials.gov