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

NCT04971395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-01-14

Study results available
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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.

Conditions

  • Healthy Participants

Interventions

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

Sponsors & Collaborators

  • Xentria, Inc.

    lead INDUSTRY

Principal Investigators

  • Ray Goldwater, MDCM, M.Sc(A), CPI · Parexel Baltimore Early Phase Clinical Unit

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2022-03-18
Completion
2022-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971395 on ClinicalTrials.gov