Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT07271693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SAD Part: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to Day 127'}, {'measure': 'MAD Part: Number of Participants With AEs', 'timeFrame': 'Up to Day 162'}, {'measure': 'SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)', 'timeFrame': 'Up to Day 127'}, {'measure': 'MAD Part: Number of Participants With DLAEs', 'timeFrame': 'Up to Day 162'}], 'secondaryOutcomes': [{'measure': 'SAD and MAD Parts: Serum Concentration of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Dose Proportionality for AUC', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'SAD and MAD Parts: Dose Proportionality for Cmax', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}, {'measure': 'MAD Part: Accumulation Ratio (Racc) of RO7806881', 'timeFrame': 'Up to Day 162'}, {'measure': 'SAD and MAD Parts: Absolute Bioavailability of RO7806881', 'timeFrame': 'SAD: Up to Day 127; MAD: Up to Day 162'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be males or females who are overtly healthy as determined by medical evaluation\n* Participants must have body weight (BW) ≥ 40 kilograms (kg) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\\^2) (inclusive)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment\n* History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis\n* Latent tuberculosis (TB) or potentially active TB\n* Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration\n* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study\n* Live vaccines within 1 month of the first screening visit or during the screening period\n* Non-live vaccines within 2 weeks prior to dosing\n* Previous exposure to RO7806881\n* Positive hepatitis C virus (HCV) antibody test result\n* Positive test results for hepatitis B infection\n* Positive human immunodeficiency virus (HIV) antibody test result\n* Positive test result consistent with cytomegalovirus (CMV) or epstein-barr virus (EBV)'}, 'identificationModule': {'nctId': 'NCT07271693', 'briefTitle': 'A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase I, Randomized, Investigator/Participant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants', 'orgStudyIdInfo': {'id': 'BP46089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RO7806881: Single Ascending Dose (SAD)', 'description': 'Participants will receive single doses of RO7806881, at 8 dose levels across different cohorts.', 'interventionNames': ['Drug: RO7806881']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: SAD', 'description': 'Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RO7806881: Multiple Ascending Doses (MAD)', 'description': 'Participants will receive multiple doses of RO7806881, at 4 dose levels across different cohorts, per the predefined dosing regimen.', 'interventionNames': ['Drug: RO7806881']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: MAD', 'description': 'Participants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RO7806881', 'type': 'DRUG', 'description': 'RO7806881 will be administered as per the schedule specified in the protocol.', 'armGroupLabels': ['RO7806881: Multiple Ascending Doses (MAD)', 'RO7806881: Single Ascending Dose (SAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered as per the schedule specified in the protocol.', 'armGroupLabels': ['Placebo: MAD', 'Placebo: SAD']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Reference Study ID Number: BP46089 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}