A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2024-10-08

Brief Summary

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The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe in healthy adult participants.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ravagalimab

Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days

Group Type EXPERIMENTAL

Ravagalimab

Intervention Type DRUG

Subcutaneous Injection

Interventions

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Ravagalimab

Subcutaneous Injection

Intervention Type DRUG

Other Intervention Names

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ABBV-323

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m\^2 after rounding to the tenth decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Participant using any over the counter and/or prescription medication, vitamins and/or herbal supplements, with the exception contraceptives or hormonal replacement therapies for females, on a regular basis.
* History of any clinically significant sensitivity or allergy to any medication or food.
* No prior exposure to ravagalimab
* Participant using any medications, vitamins, and/or herbal supplements within the 2-week period or 5 half-lives (whichever is longer) prior to study drug administration.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes