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NCT06401213Recruiting

A First-in-Human Safety Trial of MTX-463

MTX-463-I101: A Phase 1 Randomized, Double-Blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-463 in Healthy Adults
Mediar TherapeuticsPhase 1ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Healthy
Drug/Device/Intervention
MTX-463
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Mediar Therapeutics
Location
Salt Lake City, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Apr 15, 2024
End date
Nov 16, 2024
Enrollment
56 participants
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
ObesitySeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulHealthy person accompanying sick personLifestyle-related conditionMalnutrition
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06401213
Type
Non-Device Trial
About this record

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.

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.