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| ID | Type | Description | Link |
|---|---|---|---|
| I7B-MC-DPAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3079514 | Experimental | Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion |
|
| Placebo | Placebo Comparator | Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3079514 | Drug | Administered SC |
| |
| LY3079514 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module. | Baseline to Study Completion (Up to 12 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85 | |
| PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose of placebo matching LY3079514 administered intravenous (IV) infusion or subcutaneous (SC) injection during a single occasion. |
| FG001 | LY3079514 Cohort 1 | 7 milligrams (mg) single dose of LY3079514 administered by SC injection during a single occasion. |
| FG002 | LY3079514 Cohort 2 | 21 mg single dose of LY3079514 administered by SC injection during a single occasion. |
| FG003 | LY3079514 Cohort 3 | 70 mg single dose of LY3079514 administered by SC injection during a single occasion. |
| FG004 | LY3079514 Cohort 4 | 210 mg single dose of LY3079514 administered by SC injection during a single occasion. |
| FG005 | LY3079514 Cohort 5 | 70 mg single dose of LY3079514 administered IV during a single occasion. |
| FG006 | LY3079514 Cohort 6 | 210 mg single dose of LY3079514 administered IV during a single occasion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. |
| BG001 | LY3079514 (LY) Cohort 1 | 7 mg single dose of LY3079514 administered by SC injection during a single occasion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline to Study Completion (Up to 12 Weeks) |
|
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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 | Placebo | Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye swelling | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| Drug |
Administered IV |
|
| Placebo | Drug | Administered SC |
|
| Placebo | Drug | Administered IV |
|
| SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85 |
| BG002 | LY Cohort 2 | 21 mg single dose of LY3079514 administered by SC injection during a single occasion |
| BG003 | LY Cohort 3 | 70 mg single dose of LY3079514 administered by SC during a single occasion |
| BG004 | LY Cohort 4 | 210 mg single dose of LY3079514 administered by SC during a single occasion |
| BG005 | LY Cohort 5 | 70 mg single dose of LY3079514 administered IV during a single occasion |
| BG006 | LY Cohort 6 | 210 mg single dose of LY3079514 administered IV during a single occasion |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| LY3079514 (LY) Cohort 1 |
7 mg single dose of LY3079514 administered by SC injection during a single occasion |
| OG002 | LY Cohort 2 | 21 mg single dose of LY3079514 administered by SC injection during a single occasion |
| OG003 | LY Cohort 3 | 70 mg single dose of LY3079514 administered by SC during a single occasion |
| OG004 | LY Cohort 4 | 210 mg single dose of LY3079514 administered by SC during a single occasion |
| OG005 | LY Cohort 5 | 70 mg single dose of LY3079514 administered IV during a single occasion |
| OG006 | LY Cohort 6 | 210 mg single dose of LY3079514 administered IV during a single occasion |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | All randomized participants who received at least 1 dose of study drug and had evaluable Cmax PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85 |
|
|
|
| Secondary | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 | All randomized participants who received at least 1 dose of investigational drug and had evaluable AUC PK data. Cohort 1 had zero participants analyzed and was not included in summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram•hour/milliliter (ng•h/mL) | SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85 |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | LY3079514 (LY) Cohort 1 | 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 0 | 6 | 4 | 6 |
| EG002 | LY Cohort 2 | 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 0 | 6 | 1 | 6 |
| EG003 | LY Cohort 3 | 70 mg single dose of LY3079514 administered by SC injection during a single occasion | 0 | 6 | 3 | 6 |
| EG004 | LY Cohort 4 | 210 mg single dose of LY3079514 administered by SC injection during a single occasion | 0 | 6 | 4 | 6 |
| EG005 | LY Cohort 5 | 70 mg single dose of LY3079514 administered IV during a single occasion | 0 | 6 | 3 | 6 |
| EG006 | LY Cohort 6 | 210 mg single dose of LY3079514 administered IV during a single occasion | 0 | 6 | 4 | 6 |
| Eyelid oedema | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| Periorbital oedema | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Instillation site bruise | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| Premenstrual headache | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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