Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-05 @ 6:13 PM
Study NCT ID:
NCT07245368
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm)', 'timeFrame': 'Up to 25 weeks', 'description': 'Incidence, nature, and severity of serious adverse events (SAEs)'}, {'measure': 'Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm)', 'timeFrame': 'up to 29 weeks', 'description': 'Incidence, nature, and severity of and serious adverse events (SAEs)'}, {'measure': 'Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants', 'timeFrame': 'Up to 29 weeks', 'description': 'Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma.'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers', 'timeFrame': 'Up to 29 weeks', 'description': 'Incidence and magnitude of anti-drug antibody following single or multiple doses of PRA-216'}, {'measure': 'Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers', 'timeFrame': 'Up to 29 weeks', 'description': 'Time to maximum concentration of drug in plasma following single or multiple doses of PRA-216'}, {'measure': 'Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers', 'timeFrame': 'Up to 29 weeks', 'description': 'Area under the curve following single or multiple doses of PRA-216'}, {'measure': 'Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers', 'timeFrame': 'Up to 29 weeks', 'description': 'Maximum concentration of PRA-216 in plasma following single or multiple doses of PRA-216.'}, {'measure': 'Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma', 'timeFrame': 'Up to 29 weeks', 'description': 'Incidence, nature, and severity of serious adverse events (SAEs)'}, {'measure': 'Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma', 'timeFrame': 'Up to 29 weeks', 'description': 'Incidence and magnitude of anti-drug antibody following drug administration'}, {'measure': 'Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma', 'timeFrame': 'Up to 29 weeks', 'description': 'Time to maximum concentration of drug in plasma following multiple doses of PRA-216'}, {'measure': 'Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma', 'timeFrame': 'Up to 29 weeks', 'description': 'Area under the curve of PRA-216 following multiple doses of PRA-216'}, {'measure': 'Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma', 'timeFrame': 'Up to 29 weeks', 'description': 'Maximum concentration in plasma of PRA-216 following multiple doses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['healthy volunteers', 'pharmacodynamics', 'immunogenicity', 'asthma', 'pharmacokinetics'], 'conditions': ['Mild to Moderate Asthma']}, 'descriptionModule': {'briefSummary': 'Phase 1 of this study will consist of 2 parts\n\n* Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC).\n* Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously.\n\nPhase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase will be determined from Phase 1.', 'detailedDescription': 'This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses .\n\nParticipants with mild to moderate asthma will be recruited for Phase 2a of this study, to evaluate safety of randomized, double blind, placebo controlled PRA-216. The dose of PRA-216 for this phase will be determined from Phase 1 safety, tolerability, and PK data. Additional dose levels or schedules may be used for Phase 2a, depending on data from Phase 1.\n\nThis study consists of 2 phases, as follows:\n\nPhase 1, Part 1:\n\nSAD in healthy volunteers. Study visits in this section will entail a single dose administration of PRA-216 or placebo and collection of study data.\n\nPhase 1, Part 2:\n\nMAD in healthy volunteers. Study visits in this section will entail repeat doses of PRA-216 or placebo and collection of study data.\n\nPhase 2a Participants with mild to moderate asthma will receive PRA-216 or placebo. The dose will be determined from Phase 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Phase 1\n\nInclusion Criteria:\n\n* Age 18-65\n* Must be in good health with no significant medical history\n* Willing and able to attend all study visits, comply with study requirements\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence of clinically significant condition or disease\n* Any physical or psychological condition that prohibits study completion\n* Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent\n* History of severe allergic reactions or hypersensitivity\n* Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing\n\nPhase 2a\n\nInclusion criteria:\n\n* Age 18-65\n* Must be in good health with no significant medical history\n* Willing and able to attend all study visits, comply with study requirements.\n* Able and willing to provide written informed consent\n* Documented asthma diagnosis prior for at least 12 months prior to screening.\n* Symptomatic asthma\n* Currently receiving maintenance asthma medications\n\nExclusion Criteria:\n\n* Evidence of clinically significant condition or disease\n* Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent\n* Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing\n* History of severe allergic reactions or hypersensitivity\n* Current or former smoker with a smoking history of ≥10 pack-years\n* Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening\n* Other investigational agent(s) within 30 days of dosing"}, 'identificationModule': {'nctId': 'NCT07245368', 'briefTitle': 'Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prana Therapies Inc'}, 'officialTitle': 'A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma', 'orgStudyIdInfo': {'id': 'PRA-216-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1, Part 1: SAD Cohorts: Active Drug', 'description': 'Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format.', 'interventionNames': ['Drug: PRA-216']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 1, Part 1: SAD Cohorts: Placebo', 'description': 'Healthy volunteers will receive a single dose of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1, Part 2: MAD Cohort: Active Drug', 'description': 'Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format.', 'interventionNames': ['Drug: PRA-216']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 1, Part 2 MAD Cohort: Placebo Comparator', 'description': 'Healthy volunteers will receive repeated doses of placebo comparator.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a: Participants with mild to moderate asthma-active drug', 'description': 'Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216.', 'interventionNames': ['Drug: PRA-216']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2a: Participants with mild to moderate asthma-placebo', 'description': 'Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PRA-216', 'type': 'DRUG', 'description': 'biologic', 'armGroupLabels': ['Phase 1, Part 1: SAD Cohorts: Active Drug', 'Phase 1, Part 2: MAD Cohort: Active Drug', 'Phase 2a: Participants with mild to moderate asthma-active drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo for PRA-216', 'armGroupLabels': ['Phase 1, Part 1: SAD Cohorts: Placebo', 'Phase 1, Part 2 MAD Cohort: Placebo Comparator', 'Phase 2a: Participants with mild to moderate asthma-placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6027', 'city': 'Joondalup', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'enquiries@linear.org.au', 'phone': '011 61 88 6382 5110'}], 'facility': 'Linear', 'geoPoint': {'lat': -31.74445, 'lon': 115.76835}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'site contact', 'role': 'CONTACT', 'email': 'enquiries@linear.org.au', 'phone': '08 6382 5110'}], 'facility': 'Linear', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'centralContacts': [{'name': 'Linear site contact', 'role': 'CONTACT', 'email': 'enquiries@linear.org.au', 'phone': '+61 (0)8 6382 5110'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prana Therapies Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}