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The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 SAD | Experimental | NGM282 Dose 1 vs Placebo |
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| Cohort 2 SAD | Experimental | NGM282 Dose 2 vs Placebo |
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| Cohort 3 SAD | Experimental | NGM282 Dose 3 vs Placebo |
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| Cohort 4 SAD | Experimental | NGM282 Dose 4 vs Placebo |
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| Cohort 5 SAD | Experimental | NGM282 Dose 5 vs Placebo |
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| Cohort 6 SAD | Experimental | NGM282 Dose 6 vs Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM282 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. | 7 days and 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. | 7 days and 14 days |
| Pharmacodynamics | To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex M DePaoli, MD | NGM Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Perth | Western Australia | 6009 | Australia |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000710649 | aldafermin |
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| Cohort 7 MAD | Experimental | NGM282 Dose 1 vs Placebo |
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| Cohort 8 MAD | Experimental | NGM282 Dose 2 vs Placebo |
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| Cohort 9 MAD | Experimental | NGM282 Dose 3 vs Placebo |
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| Cohort 10 MAD | Experimental | NGM282 Dose 4 vs Placebo |
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| Cohort 11 MAD | Experimental | NGM282 Dose 5 vs Placebo |
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| Cohort 12 MAD | Experimental | NGM282 Dose 6 vs Placebo |
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| Placebo | Biological |
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| 7 days and 14 days |