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NCT06402513

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

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
AbbVie·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
Ravagalimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AbbVie
Timeline & enrollment
Phase
Phase 1
Start date
Jun 24, 2024
End date
Oct 09, 2024
Enrollment
12 participants
Primary outcome

Maximum Observed Plasma Concentration (Cmax),Time to Maximum Observed Plasma Concentration (Tmax),Apparent Terminal Phase Elimination Rate Constant (β),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),The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞),Number of Anti-drug antibody (ADA) Titers,Number of Participants with Adverse Events

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.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06402513
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06402513 through Pure Global AI's free database. This Phase 1 trial is sponsored by AbbVie and is currently Not yet recruiting. The study focuses on Healthy Volunteers. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.