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Monoclonal Antibodies

LY3471851 (Test formulation) for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Nektar Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 56 days postdose

Awards & highlights

Study Summary

This trial will compare the absorption and removal of two different formulations of LY3471851 in healthy participants, as well as any potential side effects. Participants will receive the study drug for 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 56 days postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 56 days postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 56 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: LY3471851 (Test) + LevocetirizineExperimental Treatment2 Interventions

LY3471851 administered SC in combination with levocetirizine given orally.

Group II: LY3471851 (Test formulation)Experimental Treatment1 Intervention

LY3471851 administered subcutaneously (SC).

Group III: LY3471851 (Reference formulation)Active Control1 Intervention

LY3471851 administered SC.

Group IV: PlaceboPlacebo Group1 Intervention

Placebo administered SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3471851

2021

Completed Phase 2

~670

Levocetirizine

2012

Completed Phase 4

~14570

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor

58 Previous Clinical Trials

10,301 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,617 Previous Clinical Trials

3,201,159 Total Patients Enrolled

Study DirectorStudy DirectorNektar Therapeutics

1,208 Previous Clinical Trials

489,654 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of legal age being admitted for participation in this trial?

"Within this clinical trial, the minimum age to participate is 18 while the cut-off for maximum age is 64."

Answered by AI

What is the extent of enrolment in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this scientific research project is currently enrolling participants. It was initially published on October 5th 2022 and has recently been updated on October 18th 2022. 42 subjects are needed from one medical centre for the trial's completion."

Answered by AI

Has the regulatory body accepted LY3471851 (Test formulation) for public use?

"Our team has determined that the safety of LY3471851 (Test formulation) is a 1 due to its Phase 1 trial status, which implies there is only minimal evidence of efficacy and protection."

Answered by AI

Are there vacancies available for participation in this clinical research?

"According to the information stored on clinicaltrials.gov, this trial is open for participants and has been since October 5th 2022. The entry was last modified a few weeks later on 18th of that month."

Answered by AI

Am I eligible to enroll in this trial?

"This research project is looking for 42 individuals between 18 and 64 years old who would qualify as healthy subjects (HS). Necessary qualifications include: displaying good health through medical records/examinations, possessing a body weight of at least 45 kilograms (kg) and having a body mass index ranging from 18.0 to 32.0 kilograms per square meter (kg/m²), Male and female candidates must commit to using contraceptives when applicable."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I Study of LY3471851 in Healthy Participants

2022. "A Phase I Study of LY3471851 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05565729.