Celsius Therapeutics has initiated the dosing of healthy volunteers in its first-in-human Phase I clinical trial of CEL383 to treat inflammatory bowel disease (IBD).
The single ascending dose, placebo-controlled, double-blind, randomised study is designed to assess the pharmacokinetics, tolerability, and safety of the anti-triggering receptor expressed on myeloid cells-1 (TREM-1) antibody CEL383.
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Approximately 48 healthy adult male or female subjects aged 19 to 64 years were randomised to receive CEL383 or a placebo.
The study’s primary outcome measures include treatment-emergent adverse events.
Cmax, Tmax, t1/2, area under the curve, and incidences of anti-drug antibodies, as determined after a single ascending dose through day one to day 85, are the secondary outcome measures.
The study also includes an exploratory assessment of target engagement, as measured by receptor occupancy.
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By GlobalDataCelsius president and CEO Tariq Kassum said: “The initiation of this study marks an important milestone for Celsius as we advance the first clinical candidate identified through our SCOPE platform into the clinic.
“A substantial and growing body of evidence shows that TREM-1 plays a central role in ulcerative colitis and Crohn’s disease, chronic inflammatory conditions that can significantly impact patient lives.
“We believe a precision therapy like CEL383 has the potential to offer a clinically meaningful treatment option that could improve the quality of life for people suffering from IBD.”
Celsius’ first clinical candidate CEL383 inhibits TREM1 signalling and reduces levels of multiple inflammatory mediators such as TNFα and IL23.
The company is engaged in developing precision medicines for treating inflammatory disease by using single-cell RNA sequencing and human biology at scale.
