A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe
- Registration Number
- NCT06402513
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ravagalimab Ravagalimab Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Approximately up to 71 days Maximum Observed Plasma Concentration (Cmax)
Apparent Terminal Phase Elimination Rate Constant (β) Approximately up to 71 days Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2) Approximately up to 71 days The Terminal Phase Elimination Half-Life (t1/2)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) Approximately up to 71 days The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Number of Anti-drug antibody (ADA) Titers Approximately up to 71 days Incidence of anti-drug antibodies
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 Time of the Last Measurable Concentration (AUCt)
Number of Participants with Adverse Events Approximately up to 85 days 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.
Time to Maximum Observed Plasma Concentration (Tmax) Approximately up to 71 days Time to Maximum Observed Plasma Concentration (Tmax)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 265325
🇺🇸Grayslake, Illinois, United States