A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-10-23

Brief Summary

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This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, multicenter, open-label study in healthy adult participants.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants receiving depemokimab via a SSD

Group Type EXPERIMENTAL

Depemokimab

Intervention Type BIOLOGICAL

Depemokimab will be administered via a SSD or autoinjector.

Participants receiving depemokimab via an autoinjector

Group Type EXPERIMENTAL

Depemokimab

Intervention Type BIOLOGICAL

Depemokimab will be administered via a SSD or autoinjector.

Interventions

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Depemokimab

Depemokimab will be administered via a SSD or autoinjector.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
* Body weight greater than or equal to (\>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
* Women who have the potential to become pregnant must use a form of highly-effective contraception.
* Capable of giving signed informed consent.

Exclusion Criteria

* History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
* Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance.
* Current evidence or recent history of an infective illness.
* A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
* Clinically significant abnormalities.
* Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening.
* Recent prior or concurrent clinical study experience.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes