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Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants

Healthy Participants Clinical Trial

Official title:
A Randomized, Double-blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants

Clinical Trial Summary

This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.

Clinical Trial Description

A total of 24 normal healthy adult participants will be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort. Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo on Day 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04971395
Study type Interventional
Source Xentria, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 25, 2021
Completion date March 18, 2022
View Details
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