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| Name | Class |
|---|---|
| COUR Pharmaceutical Development Company, Inc. | INDUSTRY |
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This study is to characterize the safety and tolerability of an investigational drug called TIMP-GLIA when either one or two intravenous doses are given to subjects with celiac disease. The way the body reacts to TIMP-GLIA is being checked by laboratory tests of the blood and urine, and study subject health will also be monitored by vital signs such as blood pressure, electrocardiogram (ECG), and physical examination.
This study is a 2-part, multicenter study. In Part A, eligible subjects will be enrolled into escalating dose cohorts (n = 2/cohort for 2 dose levels followed by n = 3/cohort for 4 dose levels). TIMP-GLIA will be administered as a single intravenous (IV) infusion on Day 1. A staggered dosing strategy will be used in Part A. Subjects will undergo medical observation in the clinic for at least 48 hours after dosing and participate in outpatient follow-up visits. Adverse events (AEs), vital signs, and electrocardiograms (ECGs) and laboratory data (serum chemistry, coagulation, hematology and urinalysis, cytokines) will be assessed by a Safety Committee before the next cohort will be dosed at a higher dose level.
After completion of Part A and confirmation by the Safety Committee to proceed, eligible subjects (n=3) will receive two IV infusions of TIMP-GLIA, 7 days apart, on Day 1 and on Day 8. Each subject in Part B will be observed in clinic for 48 hours after each dose and undergo similar testing and follow-up visits as in Part A.
The safety and pharmacokinetic profile of TIMP-GLIA will be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Cohort 1: 0.1 mg/kg | Experimental | TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. |
|
| Part A, Cohort 2: 0.5 mg/kg | Experimental | TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. |
|
| Part A, Cohort 3: 1.0 mg/kg | Experimental | TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. |
|
| Part A, Cohort 4: 2.0 mg/kg | Experimental | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. |
|
| Part A, Cohort 5: 4.0 mg/kg | Experimental | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. |
|
| Part A, Cohort 6: 8.0 mg/kg | Experimental | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIMP-GLIA | Drug | intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 180 | |
| Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events | AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Drug-related adverse events are those that the investigator assessed as possibly or probably related to the study treatment. | From Day 1 up to Day 180 |
| Number of Participants With Clinically Significant Physical Examination Findings | From Day 1 up to Day 60 | |
| Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings | From Day 1 up to Day 60 | |
| Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels | From Day 1 up to Day 60 | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values | From Day 1 up to Day 60 | |
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3 | Baseline is defined as Day 1 pre-dose. | Baseline (Day 1 pre-dose) and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose | |
| Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32216 | United States | ||
| Mass General Hospital Translational and Clinical Research Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33722583 | Derived | Kelly CP, Murray JA, Leffler DA, Getts DR, Bledsoe AC, Smithson G, First MR, Morris A, Boyne M, Elhofy A, Wu TT, Podojil JR, Miller SD; TAK-101 Study Group. TAK-101 Nanoparticles Induce Gluten-Specific Tolerance in Celiac Disease: A Randomized, Double-Blind, Placebo-Controlled Study. Gastroenterology. 2021 Jul;161(1):66-80.e8. doi: 10.1053/j.gastro.2021.03.014. Epub 2021 Mar 17. |
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Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants diagnosed with celiac disease (CD) were enrolled to receive TIMP-GLIA as a single dose escalation of 0.1 milligram per kilogram (mg/kg), 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg, 8.0 mg/kg in Part A; and TIMP-GLIA as a two dose escalation of 2.0 mg/kg, 4.0 mg/kg, 8.0 mg/kg in Part B.
Participants took part in the study at 5 investigative sites in the United States from 23 January 2018 to 22 July 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Cohort 1: 0.1 mg/kg | TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. |
| FG001 | Part A, Cohort 2: 0.5 mg/kg | TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. |
| FG002 | Part A, Cohort 3: 1.0 mg/kg | TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. |
| FG003 | Part A, Cohort 4: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. |
| FG004 | Part A, Cohort 5: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. |
| FG005 | Part A, Cohort 6: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. |
| FG006 | Part B, Cohort 1: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| FG007 | Part B, Cohort 2: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| FG008 | Part B, Cohort 3: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Cohort 1: 0.1 mg/kg | TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. |
| BG001 | Part A, Cohort 2: 0.5 mg/kg | TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. |
| 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 Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 180 |
|
TEAEs are adverse events that started after the first dose of study drug up to Day 180
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | Part A, Cohort 1: 0.1 mg/kg | TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.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 | Sep 11, 2018 | May 20, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2018 | May 20, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Single ascending dose followed by repeat dose.
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|
| Part B, Cohort 1: 2.0 mg/kg | Experimental | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
|
| Part B, Cohort 2: 4.0 mg/kg | Experimental | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
|
| Part B, Cohort 3: 8.0 mg/kg | Experimental | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
|
|
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7 |
Baseline is defined as Day 1 pre-dose. |
| Baseline (Day 1 pre-dose) and Day 7 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8 | Baseline is defined as Day 1 pre-dose. | Baseline (Day 1 pre-dose) and Day 8 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10 | Baseline is defined as Day 1 pre-dose. | Baseline (Day 1 pre-dose) and Day 10 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14 | Baseline is defined as Day 1 pre-dose. | Baseline (Day 1 pre-dose) and Day 14 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38 | Baseline is defined as Day 1 pre-dose. | Baseline (Day 1 pre-dose) and Day 38 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60 | Baseline is defined as Day 1 pre-dose. | Baseline (Day 1 pre-dose) and Day 60 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1 | Baseline was defined as Day 1 Pre-dose. | Baseline (Day 1 pre-dose) and 15 minutes (min) post-dose on Day 1 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1 | Baseline was defined as Day 1 Pre-dose. | Baseline (Day 1 pre-dose) and 30 min post-dose on Day 1 |
| Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2 | Baseline was defined as Day 1 Pre-dose. | Baseline (Day 1 pre-dose) and Day 2 |
| Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis | From Day 1 up to Day 60 |
| Part A (Greater Than or Equal to [>=] 4.0 mg/kg) and Part B: Number of Participants With Clinically Significant Change From Baseline in Gliadin-Specific T-cell Proliferation and Cytokine Release Markers | Part A (>=4.0 mg/kg): Day 1 pre-dose up to 144 hours post-dose on Day 7; Part B: Day 8 pre-dose up to 144 hours post-dose on Day 14 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | From Day 1 up to Day 60 |
| Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
| AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
| Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
| T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Mayo Gastroenterology Research Unit | Rochester | Minnesota | 55905 | United States |
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |
| BG002 | Part A, Cohort 3: 1.0 mg/kg | TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. |
| BG003 | Part A, Cohort 4: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. |
| BG004 | Part A, Cohort 5: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. |
| BG005 | Part A, Cohort 6: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. |
| BG006 | Part B, Cohort 1: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| BG007 | Part B, Cohort 2: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| BG008 | Part B, Cohort 3: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| BG009 | 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 | Count of Participants | Participants |
|
| Part A, Cohort 3: 1.0 mg/kg |
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. |
| OG003 | Part A, Cohort 4: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. |
| OG004 | Part A, Cohort 5: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. |
| OG005 | Part A, Cohort 6: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. |
| OG006 | Part B, Cohort 1: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| OG007 | Part B, Cohort 2: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| OG008 | Part B, Cohort 3: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
|
|
| Primary | Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events | AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Drug-related adverse events are those that the investigator assessed as possibly or probably related to the study treatment. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 180 |
|
|
|
| Primary | Number of Participants With Clinically Significant Physical Examination Findings | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 60 |
|
|
|
| Primary | Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 60 |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 60 |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 60 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | units per milliliter (U/ml) | Baseline (Day 1 pre-dose) and Day 3 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | U/ml | Baseline (Day 1 pre-dose) and Day 7 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. The safety analysis population where data at specified time points were available. | Posted | Mean | Standard Deviation | U/ml | Baseline (Day 1 pre-dose) and Day 8 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | U/ml | Baseline (Day 1 pre-dose) and Day 10 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | U/ml | Baseline (Day 1 pre-dose) and Day 14 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. The safety analysis population where data at specified time points were available. | Posted | Mean | Standard Deviation | U/ml | Baseline (Day 1 pre-dose) and Day 38 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60 | Baseline is defined as Day 1 pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | U/ml | Baseline (Day 1 pre-dose) and Day 60 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1 | Baseline was defined as Day 1 Pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline (Day 1 pre-dose) and 15 minutes (min) post-dose on Day 1 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1 | Baseline was defined as Day 1 Pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 1 pre-dose) and 30 min post-dose on Day 1 |
|
|
|
| Primary | Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2 | Baseline was defined as Day 1 Pre-dose. | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 1 pre-dose) and Day 2 |
|
|
|
| Primary | Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 60 |
|
|
|
| Primary | Part A (Greater Than or Equal to [>=] 4.0 mg/kg) and Part B: Number of Participants With Clinically Significant Change From Baseline in Gliadin-Specific T-cell Proliferation and Cytokine Release Markers | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | Part A (>=4.0 mg/kg): Day 1 pre-dose up to 144 hours post-dose on Day 7; Part B: Day 8 pre-dose up to 144 hours post-dose on Day 14 |
|
|
|
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. | Posted | Count of Participants | Participants | From Day 1 up to Day 60 |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA | The pharmacokinetic (PK) population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| Secondary | Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA | The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA | The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Median | Full Range | hour | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| Secondary | AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA | The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| Secondary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA | The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| Secondary | Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA | The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Median | Full Range | hour | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| Secondary | T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA | The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available. | Posted | Median | Full Range | hour | Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Part A, Cohort 2: 0.5 mg/kg | TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Part A, Cohort 3: 1.0 mg/kg | TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Part A, Cohort 4: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Part A, Cohort 5: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG005 | Part A, Cohort 6: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG006 | Part B, Cohort 1: 2.0 mg/kg | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG007 | Part B, Cohort 2: 4.0 mg/kg | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG008 | Part B, Cohort 3: 8.0 mg/kg | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. | 0 | 2 | 0 | 2 | 2 | 2 |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tongue geographic | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Cyst | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Medical device site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Gluten sensitivity | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Drug-related Adverse Events |
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| Change at Day 8 |
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| Change at Day 38 |
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| Baseline (Day 1 pre-dose): SC5B-9 level |
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| Change at 15 min post-dose on Day 1: SC5B-9 level |
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| Baseline (Day 1 pre-dose): SC5B-9 level |
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| Change at 30 min post-dose on Day 1: SC5B-9 level |
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| Baseline (Day 1 pre-dose): SC5B-9 level |
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| Change at Day 2: SC5B-9 level |
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| Day 8 |
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| Day 8 |
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| Day 8 |
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| Day 8 |
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| Day 8 |
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| Day 8 |
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| Day 8 |
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