protocolSection identificationModule nctId: NCT06277167, orgStudyIdInfo id: KXZY-GB05-101, briefTitle: A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-07, primaryCompletionDateStruct date: 2024-05-21, completionDateStruct date: 2024-05-21, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Kexing Biopharm Co., Ltd., class: INDUSTRY, collaborators name: Guoxin Pharmaceutical Technology (Beijing) Co., Ltd., collaborators name: The Third Hospital of Changsha, collaborators name: Beijing SSYP Data Technology Development Co.,Ltd., collaborators name: United-Power Pharma Tech（Shanghai）Co., Ltd., descriptionModule briefSummary: A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses, conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Human interferon alfa 1b inhalation solution, interventions name: Human interferon alfa 1b inhalation solution placebo, interventions name: Human interferon alfa 1b inhalation solution, interventions name: Human interferon alfa 1b inhalation solution placebo, outcomesModule primaryOutcomes measure: TEAEs, primaryOutcomes measure: (ADRs), primaryOutcomes measure: (SAE), primaryOutcomes measure: TEAEs that lead to subject discontinuation from the study, secondaryOutcomes measure: Cmax After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Tmax After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: t1/2 After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Ke After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Vd After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: MRT After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: CL After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Cmax,ss After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: Cmin,ss After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: Css_av After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: DF After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: (Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: ADA, secondaryOutcomes measure: NAb, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Third Hospital of Changsha, city: Changsha, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False