Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07108894
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, frequency, and severity of adverse events (AEs)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'Changes from baseline in laboratory parameters including general biochemistry, lipid profile, coagulation, hematology, and urinalysis', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'Changes from baseline in physical examination', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'Changes from baseline in vital signs', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'Changes from baseline in 12-lead safety ECGs', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'Incidence and severity of injection site reactions', 'timeFrame': 'Day 0 to day 337'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of ABCL575', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'Incidence of anti-ABCL575 antibodies', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; maximum plasma concentration (Cmax)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; time to maximum plasma concentration (Tmax)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; terminal rate constant (λz)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; apparent volume of distribution after extravascular administration (Vz/F)', 'timeFrame': 'Day 0 to day 337'}, {'measure': 'PK parameters; half-life (Thalf)', 'timeFrame': 'Day 0 to day 337'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo', 'detailedDescription': 'This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 4 planned cohorts (A1 to A4), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female ≥ 18 and ≤ 65 years of age at the time of screening\n* Good general health as determined through medical history and general physical examination\n* Body weight ≥ 50 and ≤ 100 Kg\n* Body mass index (BMI) between 18.5 kg/m2 and 30.0 kg/m2\n* Non- or ex-smoker (an ex-smoker defined as someone who has completely stopped using nicotine products for at least 180 days prior to study drug administration)\n* Meeting 1 of the following:\n\n 1. Is of childbearing potential or able to procreate and agrees to use an acceptable contraceptive method from at least 28 days prior to the screening visit through EOS visit\n 2. Is of nonchildbearing potential or unable to procreate\n* If male, agrees not to donate sperm from the study drug administration through EOS visit; If female, agrees not to donate or retrieve eggs from the study drug administration through EOS visit\n\nExclusion Criteria:\n\n* Pregnancy and/or lactation.\n* Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or a seated blood pressure \\< 90/50 mmHg or \\> 140/90 mmHg\n* eGFR \\< 60 mL/min/1.73 m2\n* Severe hypersensitivity reactions (like angioedema) to any drugs.\n* Presence or history of significant gastrointestinal, liver disease, kidney disease, or surgery that may affect drug bioavailability.\n* History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.\n* History or presence of multiple or severe drug allergies.\n* Evidence of any active bacterial, viral, or fungal infection\n* Disrupted skin integrity (apparent burn or dermatitis).\n* History of syncope, palpitations, or unexplained dizziness.\n* Use of prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration.\n* Use of any over-the-counter products in the 7 days prior to study drug administration.\n* Receipt of live vaccines within 5 weeks prior to screening or plans to receive live vaccines within 180 days after study drug administration.\n* History of latent or active tuberculosis.'}, 'identificationModule': {'nctId': 'NCT07108894', 'briefTitle': 'A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbCellera Biologics Inc.'}, 'officialTitle': 'A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants', 'orgStudyIdInfo': {'id': 'ABCL575-101'}, 'secondaryIdInfos': [{'id': '297628', 'type': 'OTHER', 'domain': 'Health Canada CTA control number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABCL575', 'description': 'Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection', 'interventionNames': ['Biological: ABCL575']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection', 'interventionNames': ['Biological: Placebo (Normal Saline 0.9%)']}], 'interventions': [{'name': 'ABCL575', 'type': 'BIOLOGICAL', 'description': 'Participants will receive SC injection of ABCL575', 'armGroupLabels': ['ABCL575']}, {'name': 'Placebo (Normal Saline 0.9%)', 'type': 'BIOLOGICAL', 'description': 'Participants will receive SC injection of placebo (Normal Saline 0.9%)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3P 3P1', 'city': 'Mount Royal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Participant Recruitment Agent', 'role': 'CONTACT', 'email': 'participants@altasciences.com', 'phone': '888-758-6312'}, {'name': 'Eric Sicard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Altasciences Company Inc.', 'geoPoint': {'lat': 45.51675, 'lon': -73.64918}}], 'centralContacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'clinicaltrials@abcellera.com', 'phone': '1-877-933-9037'}], 'overallOfficials': [{'name': 'Eric Sicard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altasciences Company Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbCellera Biologics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}