XTMAB-16 Phase 1

A Study of Different Doses of XTMAB-16 in Healthy Adults

Xentria is developing XTMAB-16, a monoclonal antibody targeting the inflammatory response known to occur in patients with sarcoidosis. XTMAB-16 aims to treat people with sarcoidosis. Before studying XTMAB-16 in patients with sarcoidosis, Xentria needs to learn how XTMAB-16 is processed by the body. We will observe healthy volunteers during and after taking the study drug to check for side effects.

This is a Phase 1 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. Cohorts are planned to be investigated in a sequential dose escalation manner.

What condition is being studied?

Healthy participants

What is the study testing?

Single dose of XTMAB-16 or placebo at multiple dose levels

What is the enrollment goal?

24

When is the trial being done?

Anticipated in 2021

Trial Details

Why is this trial being done?

Sarcoidosis is a chronic, multisystem inflammatory disorder characterized by the presence of granulomas, infiltration of mononuclear cells and destruction of organ microstructure. This rare disease can affect the skin, eyes, heart, and central nervous system, with >90% of cases involving the lungs. While medications for systemic organ involvement often control this disease, some patients fail to respond to initial treatments and require additional targeted therapy, resulting in significant costs and treatment burdens. This disease presents a significant unmet medical need and a highly important area of research and development for Xentria.

Criteria, Trial Cohorts, Dosage, Primary and Secondary Outcome Measures

Eligibility Criteria:

  • Be a healthy adult from 18 years of age to 45 years of age
  • Weigh between 99 - 220 pounds
  • Must not have underlying medical conditions
  • Live in the USA

Trial Cohorts:

  • Two treatment cohorts for two different doses (mg/kg) administered once through intravenous (IV) infusion
  • Intervention - Biological XTMAB-16; placebo

IV Infusion Single Dose:

  • Each Cohort will enroll 12 patients (9 on XTMAB-16 and 3 on placebo)

Primary Outcome Measure:

Safety and Tolerability: The level of risk to a participant and the degree to which an adverse event may affect day to day activities.


Secondary Outcome Measures:

SAFETY & TOLERABILITY

The level of risk to patient and the degree to which an adverse event may affect day to day activities.

IMMUNOGENICITY

A participant’s immune response after exposed to a treatment over a period of time.

PHARMAKOKINETICS

Profile that captures what the human body does to the treatment.

BIOMARKERS

Selective biological markers that help measure disease progress or a participant’s response to a treatment.


Trial Site Location

Parexel Baltimore Early Phase Clinical Unit
MedStar Harbor Hospital
3001 South Hanover Street - 7th floor
Baltimore, MD 21225
There are no other sites recruiting for this clinical trial in healthy volunteers.

Contact Us

Interested in learning more?

Complete this form to ask a question or learn more. We recommend that you talk with your healthcare provider about any clinical trial that may interest you. Please continue to check back with our website for updates.

This website uses cookies

We use cookies to improve your experience on our site. You can read more about our Cookie Policy in our Privacy policy.

Allow cookies Reject cookies