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Neuroendocrinology and Pituitary

SAT-052 - PK and Safety of JUV-161 - an Insulin-Like Growth Factor 2 Fusion Protein Therapeutic in Healthy Human Volunteers

Saturday, June 13, 2026
9:30 AM - 4:30 PM CT
Location: ENDOExpo; Poster Floor
JUV-161-101 is a combined Single ascending dose (SAD)/Multiple ascending dose (MAD) placebo-controlled study of escalating doses of JUV-161 in healthy subjects. Each cohort included 8 subjects (PBO=2). Dosing is complete; post-dose observation continues. The study remains blinded. SAD dosing (n=48) was 0.1, 0.3, 1.0, 3.0 and 5.0 mg/kg SC and 10mg/kg by SC infusion; MAD dosing (n=25) was 1.0, 3.0 and 5.0 mg/kg X3 (D1, D8, D15) SC. TEAEs were reported as mild in severity, unrelated to study drug (other than SC reactions) and resolved without sequelae. No dose-related changes were observed with regard to TEAEs, VS, ECG, hematology, chemistry. ​​Following subcutaneous administration in SAD cohorts (0.1- 5.0 mg/kg), the mean serum JUV-161 concentrations increased in a dose proportional manner. Mean (SD) t1/2 was 143 (35.8) h, 155 (28.4) h and 167 (15.1) h for cohorts SAD3 (1 mg/kg), SAD4 (3 mg/kg) and SAD5 (5 mg/kg), respectively. Following weekly SC administrations, an approximate >1.6-fold accumulation in Cmax and AUC0-72 was observed between Day 1 and Day 15 for all MAD cohorts. The mean (SD) t1/2 for Cohort 1 was calculated as 114.3 (18.72) h and Cohort 2 as 113.2 (31.42).
The overall safety profile from Study JUV-161-101 is unremarkable: no TEAEs have risen to the level of clinical concern and no serious TEAEs have been reported. Injection site reactions are mild and do not limit repeated dose administration of study drug.

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