A First-in-Human Safety Trial of MTX-463 - Trial NCT06401213
Access comprehensive clinical trial information for NCT06401213 through Pure Global AI's free database. This Phase 1 trial is sponsored by Mediar Therapeutics and is currently Recruiting. The study focuses on Healthy. Target enrollment is 56 participants.
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Study Focus
Sponsor & Location
Mediar Therapeutics
Timeline & Enrollment
Phase 1
Apr 15, 2024
Nov 16, 2024
Primary Outcome
Incidence of Treatment-Related Adverse Events in healthy volunteers,MTX-463 PK by dose will be evaluated for Cmax, as feasible,Serum sample results will be summarized for presence of Anti-Drug Antibodies during the SAD and MAD portions of the study.,MTX-463 PK by dose will be evaluated for AUC0-t, as feasible.,MTX-463 PK by dose will be evaluated for AUC0-tau (MAD only), as feasible,MTX-463 PK by dose will be evaluated for AUC0-∞, as feasible
Summary
A randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple
 ascending dose (MAD) study to assess the safety, tolerability, and PK of single and multiple
 ascending doses of MTX-463 administered in healthy adults.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06401213
Non-Device Trial