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

NCT06402513 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-518
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Ravagalimab; ABBV-323

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Ravagalimab

EXPERIMENTAL

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

Drug: Ravagalimab

Interventions

Ravagalimab DRUG

Subcutaneous Injection

Also known as: ABBV-323

Ravagalimab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 265325

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: June 24, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)