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| ID | Type | Description | Link |
|---|---|---|---|
| I6I-MC-LMRA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3053102 | Experimental | A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level. |
|
| Placebo | Placebo Comparator | A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3053102 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | AUC curve from time 0 to 168 hours postdose of LY3053102. | Time 0 to 168 hours after study drug administration on Day 1 |
| PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 |
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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 | 117597 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg LY3053102 | LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| FG001 | 7 mg LY3053102 | LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| FG002 | 20 mg LY3053102 | LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| FG003 | 50 mg LY3053102 | LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| FG004 | 150 mg LY3053102 | LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| FG005 | 405 mg LY3053102 | LY3053102: A single dose of 405 mg, administered subcutaneously. |
| FG006 | Placebo | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg LY3053102 | LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| BG001 | 7 mg LY3053102 |
| 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 Adverse Events (AEs) or Any Serious AEs | A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who received at least one dose of LY3053102 or placebo. | Posted | Number | participants | Baseline through Day 31 |
|
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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 | 2 mg LY3053102 | LY3053102: A single dose of 2 mg, administered subcutaneously. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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|
Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1. |
| Time 0 to 168 hours after study drug administration on Day 1 |
| Number of Participants Who Developed Anti-LY3053102 Antibodies | LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized. | Baseline, up to Day 31 |
| Singapore |
LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| BG002 | 20 mg LY3053102 | LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| BG003 | 50 mg LY3053102 | LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| BG004 | 150 mg LY3053102 | LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. |
| BG005 | 405 mg LY3053102 | LY3053102: A single dose of 405 mg, administered subcutaneously. |
| BG006 | Placebo | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort. |
| BG007 | Total | Total of all reporting groups |
| 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 |
|
| OG002 |
| 20 mg LY3053102 |
LY3053102: A single dose of 20 mg, administered subcutaneously. |
| OG003 | 50 mg LY3053102 | LY3053102: A single dose of 50 mg, administered subcutaneously. |
| OG004 | 150 mg LY3053102 | LY3053102: A single dose of 150 mg, administered subcutaneously. |
| OG005 | 405 mg LY3053102 | LY3053102: A single dose of 405 mg, administered subcutaneously. |
| OG006 | Placebo | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | AUC curve from time 0 to 168 hours postdose of LY3053102. | Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter | Time 0 to 168 hours after study drug administration on Day 1 |
|
|
|
| Secondary | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1. | Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter | Time 0 to 168 hours after study drug administration on Day 1 |
|
|
|
| Secondary | Number of Participants Who Developed Anti-LY3053102 Antibodies | LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized. | Participants who received at least one dose of LY3053102 or placebo and with evaluable anti-drug (LY3053102) ADA data. | Posted | Number | participants | Baseline, up to Day 31 |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 7 mg LY3053102 | LY3053102: A single dose of 7 mg, administered subcutaneously. | 0 | 6 | 6 | 6 |
| EG002 | 20 mg LY3053102 | LY3053102: A single dose of 20 mg, administered subcutaneously. | 0 | 6 | 4 | 6 |
| EG003 | 50 mg LY3053102 | LY3053102: A single dose of 50 mg, administered subcutaneously. | 0 | 5 | 4 | 5 |
| EG004 | 150 mg LY3053102 | LY3053102: A single dose of 150 mg, administered subcutaneously. | 0 | 6 | 6 | 6 |
| EG005 | 405 mg LY3053102 | LY3053102: A single dose of 405 mg, administered subcutaneously. | 0 | 6 | 5 | 6 |
| EG006 | Placebo | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort. | 0 | 6 | 6 | 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Temperature intolerance | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Tobacco abuse | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Day 29 |
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