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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06402513

Run by

AbbVie

People needed

12

Starts

2024-06-24

Expected to finish

2024-10-08

Last updated by the study team

2024-10-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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