Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT06425861
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2024-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First in Human Trial Evaluating THB335 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2024-05-15', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Treatment-Related Adverse Events', 'timeFrame': 'Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study)'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Part 1, and Part 2 on Day 1. Part 2 on Day 14'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': 'Part 1, and Part 2 on Day 1. Part 2 on Day 14'}, {'measure': 'Area under the plasma concentration-time curve (AUC)', 'timeFrame': 'Part 1, and Part 2 on Day 1. Part 2 on Day 14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part 3).', 'detailedDescription': 'THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells.\n\nThe study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations\n* Males or females, of any race, between 18 and 65 years of age, inclusive.\n* Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures\n* Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder\n* Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study\n* A positive urine drug screen/alcohol breath test\n* The participant currently smokes, vapes, or uses nicotine-containing products.'}, 'identificationModule': {'nctId': 'NCT06425861', 'briefTitle': 'A First in Human Trial Evaluating THB335 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Third Harmonic Bio, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants', 'orgStudyIdInfo': {'id': 'THB335-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THB335 single dose', 'description': 'Single dose of THB335 fasted', 'interventionNames': ['Drug: THB335 single dose']}, {'type': 'EXPERIMENTAL', 'label': 'THB335 fasted and fed', 'description': 'Single dose of THB335 fasted and then fed', 'interventionNames': ['Drug: THB335 fasted/fed']}, {'type': 'EXPERIMENTAL', 'label': 'THB335 multiple dose', 'description': '14 days of multiple ascending doses of THB335', 'interventionNames': ['Drug: THB335 multiple dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single dose placebo', 'description': 'Single dose of placebo capsule, fasted', 'interventionNames': ['Drug: Single dose placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fasted and fed placebo', 'description': 'Single dose of placebo capsule fasted and then fed', 'interventionNames': ['Drug: Placebo fasted/fed']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Multiple dose placebo', 'description': '14 days of multiple doses of placebo capsule', 'interventionNames': ['Drug: Multiple dose placebo']}], 'interventions': [{'name': 'THB335 single dose', 'type': 'DRUG', 'description': 'Single dose as oral capsule', 'armGroupLabels': ['THB335 single dose']}, {'name': 'Single dose placebo', 'type': 'DRUG', 'description': 'Single dose as oral capsule', 'armGroupLabels': ['Single dose placebo']}, {'name': 'THB335 fasted/fed', 'type': 'DRUG', 'description': 'Single dose fasted and fed as oral capsule', 'armGroupLabels': ['THB335 fasted and fed']}, {'name': 'Placebo fasted/fed', 'type': 'DRUG', 'description': 'Single dose fasted and fed as oral capsule', 'armGroupLabels': ['Fasted and fed placebo']}, {'name': 'THB335 multiple dose', 'type': 'DRUG', 'description': 'Multiple ascending doses oral capsule', 'armGroupLabels': ['THB335 multiple dose']}, {'name': 'Multiple dose placebo', 'type': 'DRUG', 'description': 'Multiple doses oral capsule', 'armGroupLabels': ['Multiple dose placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'QPS Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QPS Holdings LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Harmonic Bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}