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

A Phase 1 Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Ravagalimab

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 265325

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ravagalimab; Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days	Drug: Ravagalimab; Subcutaneous Injection; Other Names: ABBV-323

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	Approximately up to 71 days
Time to Maximum Observed Plasma Concentration (Tmax)	Time to Maximum Observed Plasma Concentration (Tmax)	Approximately up to 71 days
Apparent Terminal Phase Elimination Rate Constant (β)	Apparent Terminal Phase Elimination Rate Constant (β)	Approximately up to 71 days
The Terminal Phase Elimination Half-Life (t1/2)	The Terminal Phase Elimination Half-Life (t1/2)	Approximately up to 71 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	Approximately up to 71 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)	Approximately up to 71 days
Number of Anti-drug antibody (ADA) Titers	Incidence of anti-drug antibodies	Approximately up to 71 days
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Approximately up to 85 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Ravagalimab; ABBV-323
• Other Study ID Numbers: M24-518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No