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| ID | Type | Description | Link |
|---|---|---|---|
| I5M-FW-FABA | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to evaluate the following in healthy participants: 1) LY2928057 safety, including any side effects possibly associated with LY2928057; 2) how the body processes LY2928057; 3) effect of LY2928057 on blood iron levels; and 4) immune system reactions to LY2928057.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single intravenous placebo dose. |
|
| 30 mg LY2928057 (Cohort 1) | Experimental | Day 1: single 30-milligram (mg) LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057. |
|
| 100 mg LY2928057 (Cohort 2) | Experimental | Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. |
|
| 300 mg LY2928057 (Cohort 3) | Experimental | Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single intravenous placebo dose. |
| |
| LY2928057 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Adverse Effects | A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module. | Baseline through Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Area Under the Curve (AUC) | Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-∞). | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
| Pharmacokinetics, Maximum Concentration (Cmax) |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30677788 | Derived | Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single intravenous placebo dose. |
| FG001 | 30 mg LY2928057 | Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057. |
| FG002 | 100 mg LY2928057 | Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. |
| FG003 | 300 mg LY2928057 | Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. |
| FG004 | 1000 mg LY2928057 | Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single intravenous placebo dose. |
| BG001 | 30 mg LY2928057 | Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057. |
| 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 Clinically Significant Adverse Effects | A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module. | The analysis population included all randomized participants dosed with placebo or LY2928057, and who provided safety data at least up to and including the Day 8 assessment. | Posted | Number | participants | Baseline through Day 85 |
|
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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 intravenous placebo dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA v13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 1000 mg LY2928057 (Cohort 4) | Experimental | Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057. |
|
| Drug |
Single intravenous dose. |
|
|
| Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
| Pharmacokinetics, Time to Maximum Concentration (Tmax) | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
| Pharmacokinetics, Systemic Clearance (CL) | CL=total body clearance of LY2928057 calculated after intravenous administration. Systemic CL was derived from LY2928057 serum concentration data following intravenous administration using classical non compartmental analysis (WinNonlin version 5.3). | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
| Pharmacokinetics, Volume of Distribution (V) | V=LY2928057 steady-state volume of distribution (Vss) | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
| Pharmacokinetics, Terminal Half-Life (t1/2) | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
| Change From Baseline in Serum Iron | Maximum change from baseline to any point over 22 days post-infusion. | Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22 |
| Number of Participants Forming Antibody to LY2928057 | Baseline through Day 85 |
| Singapore |
| BG002 | 100 mg LY2928057 | Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. |
| BG003 | 300 mg LY2928057 | Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. |
| BG004 | 1000 mg LY2928057 | Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 100 mg LY2928057 | Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. |
| OG003 | 300 mg LY2928057 | Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. |
| OG004 | 1000 mg LY2928057 | Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057. |
|
|
| Secondary | Pharmacokinetics, Area Under the Curve (AUC) | Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-∞). | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic AUC analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
|
|
|
| Secondary | Pharmacokinetics, Maximum Concentration (Cmax) | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Cmax analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
|
|
|
| Secondary | Pharmacokinetics, Time to Maximum Concentration (Tmax) | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic tmax analyses. | Posted | Median | Full Range | hour (h) | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
|
|
|
| Secondary | Pharmacokinetics, Systemic Clearance (CL) | CL=total body clearance of LY2928057 calculated after intravenous administration. Systemic CL was derived from LY2928057 serum concentration data following intravenous administration using classical non compartmental analysis (WinNonlin version 5.3). | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic systemic CL analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
|
|
|
| Secondary | Pharmacokinetics, Volume of Distribution (V) | V=LY2928057 steady-state volume of distribution (Vss) | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Vss analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
|
|
|
| Secondary | Pharmacokinetics, Terminal Half-Life (t1/2) | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic t1/2 analyses. | Posted | Geometric Mean | Full Range | days | Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 |
|
|
|
| Secondary | Change From Baseline in Serum Iron | Maximum change from baseline to any point over 22 days post-infusion. | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided plasma data for measuring serum iron levels as the primary pharmacodynamic analysis. | Posted | Mean | Standard Deviation | microgram per deciliter (µg/dL) | Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22 |
|
|
|
| Secondary | Number of Participants Forming Antibody to LY2928057 | The analysis population included all randomized participants who received at least 1 dose of LY2928057 and antibody titer results. | Posted | Number | participants | Baseline through Day 85 |
|
|
|
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | 30 mg LY2928057 | Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057. | 0 | 6 | 6 | 6 |
| EG002 | 100 mg LY2928057 | Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. | 0 | 6 | 5 | 6 |
| EG003 | 300 mg LY2928057 | Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. | 0 | 6 | 5 | 6 |
| EG004 | 1000 mg LY2928057 | Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057. | 0 | 6 | 6 | 6 |
| Eye swelling | Eye disorders | MedDRA v13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v13.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Infusion site haematoma | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Vessel puncture site reaction | General disorders | MedDRA v13.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v13.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v13.1 | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA v13.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v13.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Systematic Assessment |
|
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