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This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPP593 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPP593 | Drug | Oral, twice a day. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Number and severity of adverse events across trial period | Baseline to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Strength | Day 1 to Day 42 | |
| Changes on Muscle Related Biomarkers | Day 1 to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following abnormalities at Screening Visit and Baseline:
Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
Has received HPP593 in a previous clinical trial.
Smoking within 6 month prior to Day -1.
Michigan Alcohol Screening Test score greater than 2.
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| Name | Affiliation | Role |
|---|---|---|
| Shulin Wang, M.D. | High Point Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine Division of Geriatrics and Nutritional Studies | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D018476 | Hypokinesia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| Drug |
Oral, twice a day. |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020820 | Dyskinesias |