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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ravagalimab | Experimental | Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravagalimab | Drug | Subcutaneous Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | Approximately up to 71 days |
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 71 days |
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent Terminal Phase Elimination Rate Constant (β) | Approximately up to 71 days |
| The Terminal Phase Elimination Half-Life (t1/2) | The Terminal Phase Elimination Half-Life (t1/2) | 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) | 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∞) | Approximately up to 71 days |
| Number of Anti-drug antibody (ADA) Titers | Incidence of anti-drug antibodies | Approximately up to 71 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 265325 | Grayslake | Illinois | 60030 | United States |
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| 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. | Approximately up to 85 days |