Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT06821750
Status:
TERMINATED
Last Update Posted:
2025-10-22
First Post:
2025-02-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Treatment Emergent Adverse Events Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35'}, {'measure': 'Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses', 'timeFrame': 'Baseline up to approximately Day 35'}, {'measure': 'Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses', 'timeFrame': 'Baseline up to approximately Day 35'}, {'measure': 'Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses', 'timeFrame': 'Baseline up to approximately Day 35'}, {'measure': 'Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64'}, {'measure': 'Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses', 'timeFrame': 'Baseline up to approximately Day 64'}, {'measure': 'Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses', 'timeFrame': 'Baseline up to approximately Day 64'}, {'measure': 'Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses', 'timeFrame': 'Baseline up to approximately Day 64'}, {'measure': 'Number of Participants with Serious Adverse Events Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35'}, {'measure': 'Number of Participants with Serious Adverse Events Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35'}, {'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35'}, {'measure': 'Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35', 'description': 'If data permit'}, {'measure': 'Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35', 'description': 'If data permit'}, {'measure': 'Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64'}, {'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64'}, {'measure': 'Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64', 'description': 'If data permit'}, {'measure': 'Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses', 'timeFrame': 'Day 1 up to approximately Day 35'}, {'measure': 'Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses', 'timeFrame': 'Day up to approximately Day 35', 'description': 'If appropriate'}, {'measure': 'Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64'}, {'measure': 'Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses', 'timeFrame': 'Day 1 up to approximately Day 64', 'description': 'If appropriate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5271001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years\n* Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg\n* for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.\n\nKey Exclusion Criteria:\n\n* Evidence or history of clinically significant medical or psychiatric conditions\n* Prior or current use of any prohibited medications\n* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening\n* Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies\n* Use of tobacco/nicotine containing products'}, 'identificationModule': {'nctId': 'NCT06821750', 'briefTitle': 'A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE SUBCUTANEOUS DOSES OF PF-07314470 IN HEALTHY PARTICIPANTS', 'orgStudyIdInfo': {'id': 'C5271001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14', 'description': 'Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels', 'interventionNames': ['Biological: PF-07314470']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14', 'description': 'Participants will receive a single dose of placebo for PF-07314470', 'interventionNames': ['Biological: Placebo for PF-07314470']}, {'type': 'EXPERIMENTAL', 'label': 'PF-07314470; Cohorts 9 to 13', 'description': 'Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses.', 'interventionNames': ['Biological: PF-07314470']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for PF-07314470; Cohorts 9 to 13', 'description': 'Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses.', 'interventionNames': ['Biological: Placebo for PF-07314470']}], 'interventions': [{'name': 'PF-07314470', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14', 'PF-07314470; Cohorts 9 to 13']}, {'name': 'Placebo for PF-07314470', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14', 'Placebo for PF-07314470; Cohorts 9 to 13']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Clinical Research Unit - New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}