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Comparative Pharmacokinetics and Pharmacodynamics of a New Sustained-Release Growth Hormone (GH), LB03002, Versus Daily GH in Adults with GH Deficiency

Medizinische Klinik–Innenstadt, Ludwig-Maximilians Universität (M.B., N.E.), D-80336 Munich, Germany; LG Life Sciences (J.K., M.J.K.), Seoul 150-721, Korea; BioPartners GmbH (C.S.), 6340 Baar, Switzerland; Harrison Clinical Research (S.d.l.M.), D-80636 Munich, Germany; and Charite Universitätsmedizin (C.J.S.), D-10117 Berlin, Germany

Address all correspondence and requests for reprints to: Martin Bidlingmaier, M.D., Medizinische Klinik–Innenstadt, Ludwig-Maximilians-Universität, Ziemssenstrasse 1, 80336 Munich, Germany. E-mail: martin.bidlingmaier{at}med.uni-muenchen.de.

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 µg/liter at first and fifth doses) compared with daily GH (2.7 ± 2.2 µg/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.

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