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The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGNX001 | Experimental | Participants will receive IGNX001 given as a single subcutaneous dose on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive IGNX001 placebo given as a single subcutaneous dose on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGNX001 | Drug | IGNX001 given as a single subcutaneous dose on Day 1. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment Emergent Adverse Events | Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. All adverse events will be captured and assessed. | From time of dose until Exit Visit/Early Termination Visit or until AE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks). |
| Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions | A serious adverse events is an adverse event that meets the criteria of being serious as determined by the Investigator. Suspected unexpected serious adverse reactions is an event assessed as serious, related to study product, and unexpected, which are subject to expedited reporting to regulatory authorities and study Investigators. | From consent until Exit Visit/Early Termination Visit or until SAE is resolved or no further follow-up is required, whichever is longer (up to 13 weeks). |
| Number of Participants with Clinically significant Changes from Baseline - Hematology | The following list of attributes will be assessed: Hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes (white blood cells), differentials (counts): neutrophils, basophils, eosinophils, lymphocytes, and monocytes | Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks). |
| Number of Participants with Clinically Significant Changes from Baseline - Chemistry | The following list of attributes will be assessed: Aspartate aminotransferase, alanine aminotransferase, total and conjugated bilirubin, alkaline phosphatase, gamma-glutamyl-transferase, creatine phosphokinase, albumin, creatinine, blood urea nitrogen, total protein, sodium, chloride, calcium, phosphate, potassium, triglycerides, total cholesterol, glucose. | Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of IGNX001 in the Plasma | Plasma concentrations of IGNX001 will be measured by a specific and validated immunoassay. | Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks). |
| Measurement of Area under the Plasma/Serum Concentration Curve (AUC) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Sydney | Darlinghurst | New South Wales | 2010 | Australia | ||
| Monash Health, Sleep, Allergy, and Immunology |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period
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With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment.
| Placebo |
| Drug |
Placebo to IGNX001 given as a single subcutaneous dose on Day 1. |
|
| Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves | All ECGs will be obtained in supine position following a 10-minute rest. Any clinically significant ECG abnormalities will be captured and reported. | Assessed at Screening, Days 1, 15, and 85 (up to 25 weeks). |
| Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations | Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes. Body weight (kilogram) and height (meter) will be obtained with the participant's shoes and jacket or coat removed. Body mass index is calculated by dividing the participant's body weight in kilograms by the participant's height in meters, squared (kg/m2). | Assessed at Screening, Days 1, 2, 4, 8, 15, 29, 43, 57, 71, and 85 (up to 25 weeks). |
PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters.
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| Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks). |
| Peak Serum Concentration (Cmax) | PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters. Cmax - Peak concentration | Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks). |
| Time to Peak Serum Concentration (Tmax) | PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters. Tmax - Time of Cmax | Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, Day 71 and 85 (up to 13 weeks). |
| Elimination Half-life (t1/2) | PK parameters will be computed using non-compartmental analysis (NCA) using the software WinNonlin (Certara, Inc. Princeton, New Jersey). Actual times for drug administration and blood sampling will be used to compute PK parameters. Half-life for each phase of decline in concentrations - Computed from the ln-linear slope (lambda) of the regression on the terminal phase of the concentration-time curve. Half-life = ln(2)/lambda. Rules for acceptance of half-life to be based on robustness of the correlation coefficient for the ln-linear regression to be defined in the SAP. | Assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 71 and 85 (up to 13 weeks). |
| Changes Over Time to Anti-drug Antibodies | The detection and characterization of antibodies to IGNX001 will be performed using a validated assay method under the supervision of the Sponsor. | Assessed at Day 1, Day 15, Day 29, Day 57 and 85 (up to 13 weeks). |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| D007154 | Immune System Diseases |