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Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A MAR002 | Experimental | Subcutaneous injection |
|
| Dose B MAR002 | Experimental | Cohort 2 receiving single Dose B |
|
| Dose C MAR002 | Experimental | Cohort 3 receiving single Dose C |
|
| Dose D MAR002 | Experimental | Cohort 4 receiving single Dose D |
|
| Dose E MAR002 | Experimental | Cohort 5 receiving single Dose E |
|
| Dose F MAR002 | Experimental | Cohort 6 receiving multiple Dose F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAR002 | Drug | subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with TEAEs (treatment-emergent adverse events) | To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men | From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters -- Cmax | To evaluate the PK parameters through plasma concentration (Cmax) | From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| PK Parameters - Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Lane | Contact | 415-766-3610 | mar-201-info@mareatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marea Site | Recruiting | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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Randomized, Double-Blind (sponsor unblinded), placebo-controlled single ascending dose and multiple dose
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| Placebo | Drug | Subcutaneous injection |
|
To evaluate the PK parameters through plasma concentration (Tmax) |
| From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| PK Parameters - AUC | To evaluate the PK parameters through plasma concentration (AUC) | From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| PK Parameters - Half Life | To evaluate the PK parameters through plasma concentration (Half Life) | From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| PK Parameters - Clearance | To evaluate the PK parameters through plasma concentration (Clearance) | From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| PK Parameters - MRT | To evaluate the PK parameters through plasma concentration (MRT) | From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6. |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |