Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03874013 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | PHASE3 | COMPLETED | 44 | — | — | Dec 7, 2017 | Mar 6, 2020 | Aug 12, 2021 | 46 | Japan |
| NCT02418767 | Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | PHASE1 | COMPLETED | 42 | — | — | Jan 1, 2015 | Jun 1, 2015 | Sep 30, 2019 | 1 | United States |
Annual Height Velocity in cm/year after 12 months of treatment.
To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose.
MOD-4023 serum levels (T1/2, Area-Under-the-Curve, Cmax, Tmax)
| Arm | Type | Description |
|---|---|---|
| MOD-4023 Treatment Arm | EXPERIMENTAL | MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. |
| Genotropin Treatment Arm | ACTIVE_COMPARATOR | Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day). |
| Low dose | EXPERIMENTAL | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| Mid dose | EXPERIMENTAL | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| High dose | EXPERIMENTAL | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| Name | Type | Description |
|---|---|---|
| MOD-4023 | DRUG | MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN. MOD-4023 will be administered as a SC injection once weekly, using a delivery device. |
| Genotropin | DRUG | Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections. A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated. Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week). |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Pre-pubertal child aged ≥ 3 years old, and not yet 10 years for girls (9 years and 364 days) or not yet 11 years for boys (10 years and 364 days), on the date of ICF signature, with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency. 2. ...