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.

Conditions studied icon

What condition is being studied?

Healthy participants

XTMAB-16 Phase 1 study testing icon

What is the study testing?

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

Enrollment goal icon

What is the enrollment goal?


Trial completion icon

When will the trial be completed?

Completed March 2022 *Post-trial data analysis ongoing

Trial Details

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:


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


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


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


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.


A summary of results may be available approximately 1 year after trial completion.

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