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Single ascending dose of HM15211 in healthy obese subjects.
A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | HM15211 or Placebo (single dose, subcutaneous injection) |
|
| Cohort 2 | Experimental | HM15211 or Placebo (single dose, subcutaneous injection) |
|
| Cohort 3 | Experimental | HM15211 or Placebo (single dose, subcutaneous injection) |
|
| Cohort 4 | Experimental | HM15211 or Placebo (single dose, subcutaneous injection) |
|
| Cohort 5 | Experimental | HM15211 or Placebo (single dose, subcutaneous injection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15211 or Placebo | Biological | Long-acting tri-agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanmi Pharmaceuticals | Hanmi Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Investigative Site | Chula Vista | California | 91911 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | HM15211 0.01 mg/kg |
| FG001 | Cohort 2 | HM15211 0.02 mg/kg |
| FG002 | Cohort 3 | HM15211 0.04 mg/kg |
| FG003 | Cohort 4 | HM15211 0.08 mg/kg |
| FG004 | Cohort 5 | HM15211 0.12 mg/kg |
| FG005 | Placebo | Placebo matched to the volume of the dose of HM15211 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all randomized subjects (total 41)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 Active | HM15211 0.01 mg/kg |
| BG001 | Cohort 2 Active | HM15211 0.02 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products | Posted | Count of Participants | Participants | 1 month |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 Active | HM15211 0.01 mg/kg | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI disorders | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| khseo@hanmi.co.kr | HanmiPharma | +82 2 410 9042 | khseo@hanmi.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2018 | Mar 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2018 | Mar 30, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| BG002 |
| Cohort 3 Active |
HM15211 0.04 mg/kg |
| BG003 | Cohort 4 Active | HM15211 0.08 mg/kg |
| BG004 | Cohort 5 Active | HM15211 0.12 mg/kg |
| BG005 | Placebo | Placebo matched to the volume of the dose of HM15211 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Cohort 4 Active | HM15211 0.08 mg/kg |
| OG004 | Cohort 5 Active | HM15211 0.12 mg/kg |
| OG005 | Placebo | Placebo matched to the volume of the dose of HM15211 |
|
|
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Cohort 2 Active | HM15211 0.02 mg/kg | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Cohort 3 Active | HM15211 0.04 mg/kg | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Cohort 4 Active | HM15211 0.08 mg/kg | 0 | 7 | 0 | 7 | 7 | 7 |
| EG004 | Cohort 5 Active | HM15211 0.12 mg/kg | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Placebo | Placebo matched to the volume of the dose of HM15211 | 0 | 10 | 0 | 10 | 7 | 10 |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Eye disorders | Eye disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Injury, poisoning and procedural | Injury, poisoning and procedural complications | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| General disorders and administration | General disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |