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The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALRN-5281 0.015 mg/kg | Experimental | Dosage-0.015 mg/kg |
|
| ALRN-5281 0.05 mg/kg | Experimental | Dosage- 0.05 mg/kg |
|
| ALRN-5281 0.15 mg/kg | Experimental | Dosage- 0.15 mg/kg |
|
| Placebo 0.015 mg/kg | Placebo Comparator | Dosage- 0.015 mg/kg |
|
| Placebo 0.05 mg/kg | Placebo Comparator | Dosage- 0.05 mg/kg |
|
| Placebo 0.15 mg/kg | Placebo Comparator | Dosage - 0.15 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALRN-5281 0.015 mg/kg | Drug |
| ||
| ALRN-5281 0.05 mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IGF-1 | Predose, Day 1-Day 28 | |
| Serum GH | Predose, Day 1-Day 28 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley D Vince, D.O. | Vince and Associates | Principal Investigator |
| Hubert C Chen, M.D. | Aileron Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research, LLC | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| ALRN-5281 0.15 mg/kg | Drug |
|
| Placebo 0.015 mg/kg | Drug |
|
| Placebo 0.05mg/kg | Drug |
|
| Placebo 0.15mg/kg | Drug |
|
| Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14 |
| Maximum plasma concentration (Cmax) of ALRN-5281 | Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14 |
| 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 |