Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Ravagalimab, ABBV-323
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.
Interventions
DRUGRavagalimab
Subcutaneous Injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Approximately up to 71 days | Maximum Observed Plasma Concentration (Cmax) |
| Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 71 days | Time to Maximum Observed Plasma Concentration (Tmax) |
| 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 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) |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed