Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 2:57 PM
Study NCT ID:
NCT07035769
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 15 months'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of Debio 1453P', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 12', 'description': 'The PK of Debio 1453P will be evaluated in plasma.'}, {'measure': 'Urine Concentration of Debio 1453P', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 12', 'description': 'The PK of Debio 1453P will be evaluated in urine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.\n2. Be within the age range of 18 to 55 years, inclusive, at the time of screening.\n3. Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m\\^2.\n\nExclusion criteria\n\n1. History and/or physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.\n2. Any medication (including vaccines, over the counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks).\n3. History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years."}, 'identificationModule': {'nctId': 'NCT07035769', 'briefTitle': 'A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults', 'orgStudyIdInfo': {'id': 'Debio 1453-101'}, 'secondaryIdInfos': [{'id': '2024-519328-26', 'type': 'OTHER', 'domain': 'EU CT Number'}, {'id': 'U1111-1315-2035', 'type': 'OTHER', 'domain': 'WHO Universal Trial Number'}, {'id': '75A50122C00028', 'type': 'OTHER_GRANT', 'domain': 'HHS/BARDA OTA Number'}, {'id': '224842/Z/21/Z', 'type': 'OTHER_GRANT', 'domain': 'Wellcome Trust'}, {'id': 'NNF23SA0088536', 'type': 'OTHER', 'domain': 'Novo Nordisk Foundation (NNF)'}, {'id': 'Agreement Dated 1/30/2023', 'type': 'OTHER', 'domain': "Germany's Federal Ministry of Research, Technology and Space (BMFTR)"}, {'id': 'Agreement Dated 2/28/2023', 'type': 'OTHER', 'domain': 'Global Antimicrobial Resistance Innovation Fund (GAMRIF)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Single ascending dose (SAD)', 'description': 'Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.', 'interventionNames': ['Drug: Debio 1453P', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Multiple ascending dose (MAD)', 'description': 'Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part.', 'interventionNames': ['Drug: Debio 1453P', 'Drug: Placebo']}], 'interventions': [{'name': 'Debio 1453P', 'type': 'DRUG', 'description': 'Powder for oral solution', 'armGroupLabels': ['Part 1: Single ascending dose (SAD)', 'Part 2: Multiple ascending dose (MAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral solution', 'armGroupLabels': ['Part 1: Single ascending dose (SAD)', 'Part 2: Multiple ascending dose (MAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'SGS Belgium NV - Clinical Pharmacology Unit', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Debiopharm International S.A', 'role': 'CONTACT', 'email': 'clinicaltrials@debiopharm.com', 'phone': '+41213210111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}, {'name': 'Wellcome Trust', 'class': 'OTHER'}, {'name': "Germany's Federal Ministry of Research, Technology and Space (BMFTR)", 'class': 'UNKNOWN'}, {'name': 'Global Antimicrobial Resistance Innovation Fund-(GAMRIF)', 'class': 'UNKNOWN'}, {'name': 'Novo Nordisk Foundation (NNF)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}