Somapacitan's Blood Uptake Compared Across Two Strengths in Healthy Subjects

Growth Hormone Deficiency (GHD) in both children and adults necessitates lifelong replacement therapy, typically involving daily subcutaneous injections of recombinant human growth hormone. This frequent dosing regimen can lead to significant patient burden, impacting adherence and overall quality of life. The development of long-acting growth hormone formulations represents a critical advancement, aiming to reduce injection frequency and enhance patient convenience. Somapacitan is a novel, investigational long-acting growth hormone analog designed for once-weekly administration. Its unique albumin-binding technology extends its half-life, allowing for less frequent dosing while maintaining therapeutic levels. This study is a crucial early-phase investigation into the pharmacokinetic properties of somapacitan, specifically comparing how different strengths are absorbed into the bloodstream. Understanding these absorption characteristics is fundamental for establishing safe and effective dosing strategies for future clinical development and eventual patient use, addressing a key unmet need in GHD management.

This Phase 1, open-label, crossover study will enroll healthy subjects to compare the blood uptake of two different strengths of somapacitan following subcutaneous injection. Participants will receive a total of 3 injections across three separate dosing visits. Each dosing visit involves 6 in-house days with overnight stays, totaling at least 15 overnight stays at the clinic. Blood samples will be collected regularly to assess drug concentrations. Exclusion criteria include prior growth hormone treatment, Growth Hormone Deficiency, and conditions posing health risks. The study duration is 10 to 15 weeks, with 17 clinic visits.