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| ID | Type | Description | Link |
|---|---|---|---|
| J1L-AM-JZGF | Other Identifier | Eli Lilly and Company | |
| AM0010-802 | Other Identifier | ARMO BioSciences |
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| Name | Class |
|---|---|
| ARMO BioSciences | INDUSTRY |
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To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegilodecakin: Treatment A | Experimental | Participants received AM0010 (pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
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| Pegilodecakin: Treatment B | Experimental | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. |
|
| Pegilodecakin: Treatment C | Experimental | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegilodecakin | Biological | Pegilodecakin alone administered SQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin | Maximal serum concentration (Cmax) of pegilodecakin is reported. | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
| PK: Time of Maximum Concentration (Tmax) of Pegilodecakin | Time of maximum serum concentration (Tmax) of Pegilodecakin is reported. | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
| PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin | AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)], AUC from time 0 to 72 hours [AUC(0-72)] and AUC from time 0 to infinity [AUC(0-inf)] of pegilodecakin is reported. | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
| PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin | Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period. | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
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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 |
|---|---|---|---|---|---|---|
| PPD Development | Austin | Texas | 78744 | United States |
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3-way crossover study with 7 days washout period between doses.Two dose concentrations and two dose levels per weight bracket (participants who weighed at less than or equal to (≤) 80 kilogram (kg) (Body weight ≤ 80 kg) in the lower bracket and participants who weighed greater than (>) 80 kg in the higher bracket (Body weight >80 kg) were evaluated
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ABC | Period 1: Participants received AM0010 (pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 milligram/milliliter (mg/mL) administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
| FG001 | Sequence BAC | Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
| FG002 | Sequence CBA | Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence ABC | Period 1: Participants received AM0010 ((pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 milligram/milliliter (mg/mL) administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
| Units | Counts |
|---|---|
| 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 |
| 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 | Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin | Maximal serum concentration (Cmax) of pegilodecakin is reported. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/mL) | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
|
Up To 22 Days
All randomized participants who received at least one dose of study drug.
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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 | Pegilodecakin: Treatment A | Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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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 | Oct 30, 2017 | Apr 23, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2019 | Apr 23, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000632591 | pegilodecakin |
| C000622455 | AM0010 |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Sequence BAC | Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. Period 2: Participants received AM0010 ((pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
| BG002 | Sequence CBA | Period 1: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. Period 2: Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. Period 3: Participants received AM0010 (pegilodecakin) SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Pegilodecakin: Treatment B | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. |
| OG002 | Pegilodecakin: Treatment C | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. |
|
|
| Primary | PK: Time of Maximum Concentration (Tmax) of Pegilodecakin | Time of maximum serum concentration (Tmax) of Pegilodecakin is reported. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Median | Full Range | hours (h) | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
|
|
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| Primary | PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin | AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)], AUC from time 0 to 72 hours [AUC(0-72)] and AUC from time 0 to infinity [AUC(0-inf)] of pegilodecakin is reported. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*picogram per milliliter (h*pg/mL) | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
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|
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| Primary | PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin | Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] |
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | Pegilodecakin: Treatment B | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight >80 kg. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG002 | Pegilodecakin: Treatment C | Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight >80 kg. | 0 | 12 | 0 | 12 | 11 | 12 |
| Abdominal bloating | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Decreased frequency of bowel movements | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chills | General disorders | MedDRA | Systematic Assessment |
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| Flu-like symptoms | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction left upper quadrant ecchymosis | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction left upper quadrant erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction left upper quadrant pruritus | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right lower quadrant ecchymosis | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right lower quadrant erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right lower quadrant pruritus | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right lower quadrant swelling | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right upper quadrant erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right upper quadrant injection site streaking | General disorders | MedDRA | Systematic Assessment |
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| Injection site reaction right upper quadrant pruritus | General disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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PI may not publish any articles or make any presentations related to the services provided by sponsor here under with respect to a project or referring to data, information or materials generated as part of the services without the prior written consent of sponsor.
| Body Weight >80 kg |
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| Body Weight >80 kg: AUC(0-tlast) |
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| Body Weight ≤80 kg: AUC(0-72) |
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| Body Weight >80 kg: AUC(0-72) |
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| Body Weight ≤80 kg: AUC(0-inf) |
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| Body Weight >80 kg: AUC(0-inf) |
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| Body Weight >80 kg |
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