CONTEXT: LB03002 is a novel sustained-release GH preparation administered once weekly. OBJECTIVE: Our objective was to examine the pharmacokinetics, pharmacodynamics, and safety of LB03002 vs. daily GH. DESIGN AND SETTING: This open-label, crossover study compared the pharmacokinetics and pharmacodynamics of LB03002 and daily GH. PATIENTS AND OTHER PARTICIPANTS: Six male and three female patients with adult GH deficiency participated in the single-center study. INTERVENTION: Subjects were on stable daily GH treatment before the study. After a 4-wk washout with no GH, five weekly doses of LB03002 were given. MAIN OUTCOME MEASURE: GH and IGF-I concentrations were measured during the last dose of daily GH and during the first and fifth weekly doses of LB03002. RESULTS: The observed maximal serum GH concentration was approximately doubled after LB03002 (6.1 +/- 3.2 and 4.5 +/- 2.2 microg/liter at first and fifth doses) compared with daily GH (2.7 +/- 2.2 microg/liter). A sustained increase in GH concentration for more than 48 h was observed with LB03002, such that dose-normalized area under the curve (AUC) was not significantly different between daily GH and LB03002. Mean maximal serum IGF-I concentration was 34-41% greater with LB03002 than with daily GH, and AUC was 7-fold greater. However, normalized to GH dose, AUC for IGF-I was comparable. Adverse events and local reactions were acceptable, and there were no evident safety concerns with LB03002. CONCLUSIONS: Multiple weekly doses of LB03002 appeared safe and well tolerated. Comparable GH bioavailability and sustained IGF-I elevations support the use of once-weekly LB03002 to replace daily GH therapy.
RCT Entities:
CONTEXT: LB03002 is a novel sustained-release GH preparation administered once weekly. OBJECTIVE: Our objective was to examine the pharmacokinetics, pharmacodynamics, and safety of LB03002 vs. daily GH. DESIGN AND SETTING: This open-label, crossover study compared the pharmacokinetics and pharmacodynamics of LB03002 and daily GH. PATIENTS AND OTHER PARTICIPANTS: Six male and three female patients with adult GH deficiency participated in the single-center study. INTERVENTION: Subjects were on stable daily GH treatment before the study. After a 4-wk washout with no GH, five weekly doses of LB03002 were given. MAIN OUTCOME MEASURE: GH and IGF-I concentrations were measured during the last dose of daily GH and during the first and fifth weekly doses of LB03002. RESULTS: The observed maximal serum GH concentration was approximately doubled after LB03002 (6.1 +/- 3.2 and 4.5 +/- 2.2 microg/liter at first and fifth doses) compared with daily GH (2.7 +/- 2.2 microg/liter). A sustained increase in GH concentration for more than 48 h was observed with LB03002, such that dose-normalized area under the curve (AUC) was not significantly different between daily GH and LB03002. Mean maximal serum IGF-I concentration was 34-41% greater with LB03002 than with daily GH, and AUC was 7-fold greater. However, normalized to GH dose, AUC for IGF-I was comparable. Adverse events and local reactions were acceptable, and there were no evident safety concerns with LB03002. CONCLUSIONS: Multiple weekly doses of LB03002 appeared safe and well tolerated. Comparable GH bioavailability and sustained IGF-I elevations support the use of once-weekly LB03002 to replace daily GH therapy.
Authors: Kevin C J Yuen; Gerard S Conway; Vera Popovic; George R Merriam; Timothy Bailey; Amir H Hamrahian; Beverly M K Biller; Mark Kipnes; Jerome A Moore; Eric Humphriss; George M Bright; Jeffrey L Cleland Journal: J Clin Endocrinol Metab Date: 2013-04-12 Impact factor: 5.958