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.
Single dose of XTMAB-16 or placebo at multiple dose levels
Completed March 2022 *Post-trial data analysis ongoing
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.
Safety and Tolerability: The level of risk to a participant and the degree to which an adverse event may affect day to day activities.
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.
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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