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
Overview
- Phase
- Phase 1
- Intervention
- Ravagalimab
- Conditions
- Healthy Volunteers
- Sponsor
- AbbVie
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Ravagalimab
Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days
Intervention: Ravagalimab
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Approximately up to 71 days
Maximum Observed Plasma Concentration (Cmax)
Apparent Terminal Phase Elimination Rate Constant (β)
Time Frame: Approximately up to 71 days
Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2)
Time Frame: 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∞)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: Approximately up to 71 days
Time to Maximum Observed Plasma Concentration (Tmax)