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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Subcutaneous Injection
Acpru /Id# 265325
Grayslake, Illinois, United States
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Time frame: Approximately up to 71 days
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Approximately up to 71 days
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent Terminal Phase Elimination Rate Constant (β)
Time frame: Approximately up to 71 days
The Terminal Phase Elimination Half-Life (t1/2)
The Terminal Phase Elimination Half-Life (t1/2)
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)
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 Infinity (AUC∞)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Time frame: Approximately up to 71 days
Number of Anti-drug antibody (ADA) Titers
Incidence of anti-drug antibodies
Time frame: 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.
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Time frame: Approximately up to 85 days