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A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15912 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15912 | Drug | The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events of HM15912 | Number of participants with any treatment-emergent adverse events related to study medication. | after single subcutaneous (SC) doses for 44 days |
| Number of Participants With Significant Findings Observed for Hematology | after single subcutaneous (SC) doses for 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration Max Profile of HM15912 | To assess the Concentration Max profile of HM15912 after single SC doses. | after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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The planned maximum dose of HM15912 was 1.5 mg/kg; however, higher doses were allowed to be administered if safety was confirmed in previous cohorts. If dose was escalated to more than 1.5 mg/kg, Ministry of Food and Drug Safety (MFDS) approval was to be obtained.
Date of first enrollment was October 8th, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | HM15912 0.05mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| FG001 | HM15912 0.1mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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, 2020 | Oct 21, 2024 |
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| Placebo | Drug | The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
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HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| FG002 | HM15912 0.5mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| FG003 | HM15912 1.0mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| FG004 | HM15912 1.5mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| FG005 | Placebo | Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HM15912 0.05mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| BG001 | HM15912 0.1mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| BG002 | HM15912 0.5mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| BG003 | HM15912 1.0 mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| BG004 | HM15912 1.5mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| BG005 | Placebo | Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment-emergent Adverse Events of HM15912 | Number of participants with any treatment-emergent adverse events related to study medication. | Each analysis population was included in the analyses, based on the actually administered IMP and dosage. | Posted | Count of Participants | Participants | after single subcutaneous (SC) doses for 44 days |
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| Primary | Number of Participants With Significant Findings Observed for Hematology | Posted | Count of Participants | Participants | after single subcutaneous (SC) doses for 44 days |
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| Secondary | Concentration Max Profile of HM15912 | To assess the Concentration Max profile of HM15912 after single SC doses. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30 |
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Screening, Day1 to 7, Day 10, Day 17, and Day 30
An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.
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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 | HM15912 0.05mg/kg | HM15912 0.05mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | HM15912 0.1mg/kg | HM15912 0.1mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | HM15912 0.5mg/kg | HM15912 0.5mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | HM15912 1.0mg/kg | HM15912 1.0mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | HM15912 1.5mg/kg | HM15912 1.5mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Placebo | Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). | 0 | 10 | 0 | 10 | 6 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiyeon Kang | Hanmi Pharmaceutical Co., Ltd. | 8224100377 | jiyeon.kang@hanmi.co.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2020 | Oct 21, 2024 | SAP_001.pdf |
| Male |
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| Moderate TEAE |
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| No AE |
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| OG004 | HM15912 1.5mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| OG005 | Placebo | Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo. |
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| OG004 | HM15912 1.5mg/kg | HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). |
| OG005 | Placebo | Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo. |
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