NCT04971395

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Xentria, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Placebo	Single dose of 2 or 4 mg/kg
DRUG	XTMAB-16 2 mg/kg	Single dose of 2 mg/kg
DRUG	XTMAB-16 4mg/kg	Single dose of 4 mg/kg

Timeline

• Start date: 2021-06-25
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2021-07-21
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study