This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose selection for future trials.
The study is a phase II, randomized, open-label, parallel, 4 active treatment arms study to evaluate the safety, tolerability and PK/PD profile of MOD-4023 in pre-treated, normalized, GHD adults. The study is conducted in 2 stages. Stage I is a 4-week treatment period with 4 different dose levels/dosing regimens. Stage II is a 16-week treatment-extension period in which all the patients will start with the same dose (derived from stage I) and will be dose titrated to maintain IGF-1 levels within the normal range.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly
liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly
liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly
Internal Clinic in University Hospital St. Anna
Brno, Czechia
University Hospital, 2nd Department of Internal Medicine
Hradec Králové, Czechia
1. Safety and Tolerability
Adverse events (AE's), vital signs, electrocardiogram (ECG), laboratory tests, local reaction
Time frame: Following 4 weeks of MOD-4023 treatment
Maintenance of normal Insulin-like-Growth-Factor-1 (IGF-1)levels in GHDA
The primary efficacy endpoint will be the mean time interval of IGF-I levels that lay within ±1.5 SDS after the last dose administration during stage I (4w treatment) expressed in hours.
Time frame: Following 4 weeks MOD-4023 treatment
Change of IGF-I levels over time expressed in absolute and SDS values
Time frame: Following 4 and 16 weeks of MOD-4023 treatment
Change of IGFBP-3 over time expressed in absolute values
Time frame: Following 4 and 16 weeks of MOD-4023 treatment
Number of IGF-1 normalized patients in stage II
Number of patients achieving normalization of IGF-1 levels during dose titration 16-week treatment extension
Time frame: Following 16 weeks of MOD-4023 treatment
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liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, every-other week (50% of the two-weekly cumulative dose)
State Health Center, 2nd department of internal medicine
Budapest, Hungary
Semmelweis University, 2nd Clinic of Internal Medicine
Budapest, Hungary
Petz Aladár County Teaching Hospital, Department of Endocrinology, Metabolism and Diabetology
Győr, Hungary
University of Pécs, Medical School, 1st Department of Internal Medicine
Pécs, Hungary
Szeged University, 1st Internal Medicine Clinic, Endocrinology
Szeged, Hungary
Hetényi Géza Hospital and Out-Patient Clinic, 1st Department of Internal Medicine
Szolnok, Hungary
Endocrinology and Metabolism Service, Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Institute of Endocrinology, Tel Aviv-Sourasky Medical Center
Tel Aviv, Israel
...and 5 more locations