Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT07024602
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
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': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to Day 7', 'description': 'Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to Day 43', 'description': 'Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)'}], 'secondaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Up to Day 7', 'description': 'Evaluate the Area under the plasma concentration versus time curve of ASC50'}, {'measure': 'AUC', 'timeFrame': 'Up to Day 34', 'description': 'Evaluate the Area under the plasma concentration versus time curve of ASC50'}, {'measure': 'Cmax', 'timeFrame': 'Up to Day 7', 'description': 'Evaluate the Peak Plasma Concentration of ASC50'}, {'measure': 'Cmax', 'timeFrame': 'Up to Day 34', 'description': 'Evaluate the Peak Plasma Concentration of ASC50'}, {'measure': 'T1/2', 'timeFrame': 'Up to Day 7', 'description': 'Evaluate the Terminal-Phase Half-Life of ASC50'}, {'measure': 'T1/2', 'timeFrame': 'Up to Day 34', 'description': 'Evaluate the Terminal-Phase Half-Life of ASC50'}, {'measure': 'Tmax', 'timeFrame': 'Up to Day 7', 'description': 'Evaluate the time to reach the maximum concentration of ASC50'}, {'measure': 'Tmax', 'timeFrame': 'Up to Day 34', 'description': 'Evaluate the time to reach the maximum concentration of ASC50'}, {'measure': 'IL-17A', 'timeFrame': 'Up to Day 7', 'description': 'Changes in IL-17A after ASC50 administration'}, {'measure': 'IL-17A', 'timeFrame': 'Up to Day 29', 'description': 'Changes in IL-17A after ASC50 administration'}, {'measure': 'Beta Defensin-2', 'timeFrame': 'Up to Day 29', 'description': 'Changes in Beta Defensin-2 after ASC50 administration'}, {'measure': 'IL-19', 'timeFrame': 'Up to Day 29', 'description': 'Changes in IL-19 after ASC50 administration'}, {'measure': 'Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Up to Day 43', 'description': 'Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.'}, {'measure': 'Target Lesion Severity Score (TLSS)', 'timeFrame': 'Up to Day 43', 'description': 'Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASC50', 'Plaque Psoriasis'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female participants between 18 to 65 years of age inclusive, at the time of screening.\n2. Willing and able to give informed consent prior to any study specific procedures being performed.\n3. Have venous access sufficient to allow for blood sampling\n\nExclusion Criteria:\n\n1. Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.\n2. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.\n3. Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.\n4. Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study."}, 'identificationModule': {'nctId': 'NCT07024602', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'ASC50-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 1', 'description': 'Participants will receive a single ASC50 (Dose 1) administration or matching placebo', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 2', 'description': 'Participants will receive a single ASC50 (Dose 2) administration or matching placebo', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 3', 'description': 'Participants will receive a single ASC50 (Dose 3) administration or matching placebo', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 4', 'description': 'Participants will receive a single ASC50 (Dose 4) administration or matching placebo', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 5', 'description': 'Participants will receive a single ASC50 (Dose 5) administration or matching placebo', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 6', 'description': 'Participants will receive a single ASC50 (Dose 6) administration or matching placebo', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Cohort 1', 'description': 'Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Cohort 2', 'description': 'Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Cohort 3', 'description': 'Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD', 'interventionNames': ['Drug: ASC50 tablets or matching placebo']}], 'interventions': [{'name': 'ASC50 tablets or matching placebo', 'type': 'DRUG', 'description': 'Drug: ASC50 administered orally Drug: Placebo administered orally', 'armGroupLabels': ['MAD Cohort 1', 'MAD Cohort 2', 'MAD Cohort 3', 'SAD Cohort 1', 'SAD Cohort 2', 'SAD Cohort 3', 'SAD Cohort 4', 'SAD Cohort 5', 'SAD Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ascletis Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Vanessa Wang, MD', 'role': 'CONTACT', 'email': 'global.clinical@ascletis.com', 'phone': '+86 18986192094'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascletis Pharma (China) Co., Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}