Phase 1 study and population PK/PD modeling of long-acting growth hormone, GB08, to guide pediatric dosing
Authors' conclusion
GB08 provides notable advantages over traditional therapies, like short-acting GH, by enhancing treatment adherence and offering a potentially safer alternative. The findings from this study will guide dosing strategies for Phase 2 trial in children with GHD.
Study context
- Population
- Healthy adults
- Comparison
- Single-dose GB08 (0.16-2.4 mg/kg) vs placebo; Jintrolong and Norditropin as positive controls
- Outcome
- Safety, immunogenicity, PK and PD of GB08
Methodological details2 parts, randomized, double-blind, placebo-controlled, single ascending dose, open-label, parallel-group, positive control
- 2 parts
- Randomized
- Double-blind
- Placebo-controlled
- Single ascending dose
- Open-label
- Parallel-group
- Positive control
Main finding
As reported in the abstract
GB08 half-life
81.7 to 110.0 h
Optimal adult dose by PK/PD modelling
0.7 mg/kg
Optimal pediatric dose by allometric scaling pediatric PK model
0.8 mg/kg
Safety
- GB08: favorable safety profile with low immunogenicity; no serious adverse events (AEs) reported; all AEs mild to moderate
Original publication
Phase 1 study and population PK/PD modeling of long-acting growth hormone, GB08, to guide pediatric dosing. Eur J Endocrinol. Published 17 June 2025. doi:10.
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