An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2025-11-01

Brief Summary

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This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers

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Detailed Description

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Conditions

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Relative Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sonelokimab via a PFS

Group Type EXPERIMENTAL

Sonelokimab

Intervention Type DRUG

sonelokimab 120 mg administered subcutaneously via a PFS

Sonelokimab via an AI

Group Type EXPERIMENTAL

Sonelokimab

Intervention Type DRUG

sonelokimab 120 mg administered subcutaneously via an AI

Interventions

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Sonelokimab

sonelokimab 120 mg administered subcutaneously via a PFS

Intervention Type DRUG

Sonelokimab

sonelokimab 120 mg administered subcutaneously via an AI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be between 18 and 55 years of age with suitable veins for cannulation or repeated venipuncture .
* Participants must have a body weight greater than 40 kg and body mass index (BMI) between 21 and 30 kg/m2, inclusive.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physician examination, laboratory tests, and cardiac monitoring.
* Female participants are eligible to participate if they are not pregnant or breastfeeding
* Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study, unless surgically sterile.

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History of clinically significant infections.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric.
* History of hypersensitivity, intolerance, or severe adverse reaction to any drug compound, any history of anaphylaxis or angioedema, or any history of severe food allergy/intolerance requiring systemic treatment.
* Participants with transaminase and liver function test results outside of the normal reference range, following a confirmatory test, if appropriate
* Participants with other clinically significant laboratory test results that are likely to introduce additional risk factors or interfere with the study procedures or interpretation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes