Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-06 @ 9:25 PM
Study NCT ID:
NCT04198558
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anti-drug antibody incidence and titres', 'timeFrame': 'Up to 85 days', 'description': 'Anti-drug (MEDI0618) antibody incidence and titres'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Up to 85 days', 'description': 'Adverse Events'}, {'measure': 'Incidence of Treatment-Emergent Serious Adverse Events', 'timeFrame': 'Up to 85 days', 'description': 'Serious Adverse Events'}, {'measure': 'Vital Signs', 'timeFrame': 'Up to 85 days', 'description': 'Heart Rate in beats per minute'}, {'measure': 'Vital Signs', 'timeFrame': 'Up to 85 days', 'description': 'Blood pressure in mm Hg'}, {'measure': 'Body Weight', 'timeFrame': 'Up to 85 days', 'description': 'Weight in kg'}, {'measure': 'Height', 'timeFrame': 'Up to 85 days', 'description': 'Height in meters Height and weight will be combined to report BMI in kg/m\\^2'}, {'measure': 'Clinical Chemistry', 'timeFrame': 'Up to 85 days', 'description': 'Measurement of Albumin, Protein, Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, Bilirubin, Calcium, Creatine phosphokinase, C-reactive protein, Glucose, Blood urea nitrogen, Phosphate, Potassium, Sodium, Chloride and Bicarbonate'}, {'measure': 'Haematology', 'timeFrame': 'Up to 85 days', 'description': 'Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin'}, {'measure': 'Thyroid Function', 'timeFrame': 'Up to 85 days', 'description': 'Measurement of Thyroid-stimulating hormone and free thyroxine'}, {'measure': 'Renal Function', 'timeFrame': 'Up to 85 days', 'description': 'Measurement of Glomerular filtration rate'}, {'measure': 'Urinalysis', 'timeFrame': 'Up to 85 days', 'description': 'Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine'}, {'measure': '12-Lead Electrocardiogram', 'timeFrame': 'Up to 85 days', 'description': 'Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings'}, {'measure': 'Physical Examination', 'timeFrame': 'Up to 85 days', 'description': 'General physical examination'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': 'Up to 85 days', 'description': 'Peak concentration of MEDI0618 in plasma'}, {'measure': 'Time to maximum concentration (tmax)', 'timeFrame': 'Up to 85 days', 'description': 'Time to maximum concentration of MEDI0618 in plasma'}, {'measure': 'Area under the concentration versus time curve (AUC)', 'timeFrame': 'Up to 85 days', 'description': 'Calculated area under the concentration versus time curve for MEDI0618'}, {'measure': 'Terminal half-life', 'timeFrame': 'Up to 85 days', 'description': 'Time required for the plasma concentration of MEDI0618 to decrease by 50%'}, {'measure': 'Bioavailability', 'timeFrame': 'Up to 85 days', 'description': 'The fraction of MEDI0618 administered that is available to the systemic circulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Double-blind', 'Placebo-controlled', 'Safety and Tolerability Study', 'Healthy Volunteers'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7060C00001&attachmentIdentifier=a34c53be-52e3-4161-9a92-fec1c1c2e7f1&fileName=CSR_SYNOPSIS_D7060C00001_Version_1.0_final-synopsis-Redacted_06Mar2023.pdf&versionIdentifier=', 'label': 'CSR SYNOPSIS'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.', 'detailedDescription': 'This is a randomised, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers.\n\nThis study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous administration.All subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women of non-childbearing potential aged 18 to 55 years\n* Normal 12-lead ECG at screening and on day of dosing\n* Physical examinations with no significant findings at screening\n* Be able to understand and comply with protocol requirements\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational product (IP) within half-lives of the IP or 3 months, whichever is longer, prior to screening\n* Requires treatment with another biological therapeutic agent\n* Inability to comply with study-related requirements\n* History of severe allergy or hypersensitivity reactions\n* History of significant psychiatric disorder\n* Presence of any clinically significant illness\n* History of cancer\n* Any clinically important abnormality physical examination, vital signs, ECG or laboratory test'}, 'identificationModule': {'nctId': 'NCT04198558', 'briefTitle': 'A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': 'D7060C00001'}, 'secondaryIdInfos': [{'id': '2019-002128-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 4', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 5', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 6', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 7', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 8', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 9', 'description': 'MEDI0618 or placebo', 'interventionNames': ['Drug: MEDI0618', 'Drug: Placebo']}], 'interventions': [{'name': 'MEDI0618', 'type': 'DRUG', 'description': 'MEDI0618 A novel human immunoglobulin antibody', 'armGroupLabels': ['Dose Level 1', 'Dose Level 2', 'Dose Level 3', 'Dose Level 4', 'Dose Level 5', 'Dose Level 6', 'Dose Level 7', 'Dose Level 8', 'Dose Level 9']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Dose Level 1', 'Dose Level 2', 'Dose Level 3', 'Dose Level 4', 'Dose Level 5', 'Dose Level 6', 'Dose Level 7', 'Dose Level 8', 'Dose Level 9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Tharani Chessell, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Stanislav Ignatenko, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Research Organisation'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After CSR sign-off.', 'ipdSharing': 'YES', 'description': 'Anonymised individual patient-level data will be shared.', 'accessCriteria': 'Qualified researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}