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| Name | Class |
|---|---|
| WCCT Global | INDUSTRY |
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The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers.
Following a 4-week screening period, eligible male subjects will be stratified by ethnic group and will be randomized to one of six groups. On dosing day, designated as Day 1, each subject will receive single SC injection of study medication according to group allocation and will be followed up for a month for safety monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOD-4023 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions | To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose. | 30 days |
| Pharmacokinetics (PK) profile of MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose | MOD-4023 serum levels (T1/2, Area-Under-the-Curve, Cmax, Tmax) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (PD) profile (IGF-1 and IGFBP-3 levels) to MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose | IGF-1 and IGFBP-3 serum levels (T1/2, AUC, Cmax, Tmax) | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States |
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| Drug |
|
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000634267 | MOD-4023 |
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