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Inability to recruit due to COVID-19 pandemic restrictions
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| Name | Class |
|---|---|
| INC Research Australia Pty Ltd | UNKNOWN |
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First in human study of ALY688-SR administered as a subcutaneous injection
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALY688-SR | Active Comparator | single dose subcutaneous injection |
|
| Matching placebo for ALY688-SR | Placebo Comparator | single dose subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALY688-SR | Drug | single dose subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change between pre- and post-intervention safety and tolerability assessments | Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations | baseline, pre-intervention through study completion at 16 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Snyder, MD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Single dose escalation study
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Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |