XTMAB-16 Phase 1

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

Xentria is developing XTMAB-16, a type of monoclonal antibody which aims to treat people with sarcoidosis. XTMAB-16 remains under development and the safety and efficacy of it has not been determined. Before studying XTMAB-16 in patients with sarcoidosis, Xentria needed to learn how XTMAB-16 is processed by the body. We observed 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 were investigated in a sequential dose escalation manner.

Additional details on clinicaltrials.gov
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?

Twenty Four

When will the trial be completed?

Completed March 2022

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.

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 icon
Safety & Tolerability

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

Immunogenicity icon

A participant’s immune response after exposure to a treatment over a set time.

Pharmacokinetics icon

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

Biomarkers icon

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

This trial is no longer enrolling.


A lay summary can be found here. This summary includes results from this trial only. Other trials of XTMAB-16 may have different results. XTMAB-16 is currently under investigation for pulmonary sarcoidosis. The safety and effectiveness for its uses have not yet been established.

More info on XTMAB-16 Sarcoidosis

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