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A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe - Trial NCT06402513

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.

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NCT06402513
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06402513
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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

Study Focus

Healthy Volunteers

Ravagalimab

Interventional

drug

Sponsor & Location

AbbVie

Timeline & Enrollment

Phase 1

Jun 24, 2024

Oct 09, 2024

12 participants

Primary Outcome

Maximum Observed Plasma Concentration (Cmax),Time to Maximum Observed Plasma Concentration (Tmax),Apparent Terminal Phase Elimination Rate Constant (ฮฒ),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 (AUCโˆž),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 person
Routine general health check-up of armed forces
Routine general health check-up of sports teams
Routine general health check-up of inhabitants of institutions

Data Source

ClinicalTrials.gov

NCT06402513

Non-Device Trial