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Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Minoxidil
Sponsored by
Aneira Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Males between age 18 to 65 years, in general good health. Good health is defined as a subject without any active diseases. Not included in active diseases are: Migraines Non-hospitalized depression o Asthma Cholecystectomy Gilbert's syndrome Clinical diagnosis of AGA with grade II to VI hair loss on Norwood Hamilton Classification System Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator's opinion, interfere with study assessments. No known allergy to ANR-001.1 or any of its components. Subject is willing to avoid extensive sun exposure, phototherapy, or use of tanning salon for the duration of the study. Exclusion Criteria: If subjects have a BMI outside of the range of 18-35kg/m2 Subjects using a minoxidil product (e.g., Rogaine or generic Rogaine) or a latanoprost product (e.g., Xalatan or generic Xalatan) within 30 days of the start of Day 1 of the study. Subjects whose vital signs, ECG, safety labs or physical exam results are clinically significant in the opinion of the investigator. Subjects have a skin condition that, in the Investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation. Subjects with an active or recent (within 30 days before Day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.). Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test treatment. Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Primary safety and pharmacokinetic data

    Arm Description

    To obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp

    Outcomes

    Primary Outcome Measures

    Pharmacokinetic data: Cmax
    Individual and mean maximum plasma concentration (Cmax)
    Pharmacokinetic data: tmax
    Individual and mean tmax
    Pharmacokinetic data: Half-life (t1/2)
    Individual and mean half-life (t1/2)
    Pharmacokinetic data: AUC
    Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
    Pharmacokinetic data: Drug clearance
    Individual and mean apparent clearance of drug from plasma
    Safety : Skin TEAEs
    Incidence of treatment-emergent adverse events related to skin irritation at the administration site
    Safety: Systemic TEAEs
    Incident of systemic treatment-emergent adverse events
    Safety: Evaluation of QTs Interval Prolongation
    Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2023
    Last Updated
    May 16, 2023
    Sponsor
    Aneira Pharma, Inc.
    Collaborators
    DataPharm Australia, CMAX Clinical Research, Agilex Australia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05864885
    Brief Title
    Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia
    Official Title
    Phase I Study of Safety and Pharmacokinetics of Once-Daily Topical Solution in Male Subjects With Androgenetic Alopecia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 9, 2023 (Anticipated)
    Primary Completion Date
    July 17, 2023 (Anticipated)
    Study Completion Date
    July 17, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Aneira Pharma, Inc.
    Collaborators
    DataPharm Australia, CMAX Clinical Research, Agilex Australia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.
    Detailed Description
    At screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. Screening data will include demographics, medical history, concomitant medications, physical examination, weight, O2 sat, vital signs laboratory evaluation (CMP, CBC, UA), and ECG. At Day 1, a physical exam, weight, O2 sat, vital signs (including BP, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed. If criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). If there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). The study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for Study Days 1, 2, 3, 4, 5, 6, and 7. Daily subject visits will include vital signs, review of adverse events and concomitant medications. PK draws and ECGs will take place at Study Days 1, 2, 7 and 8, following the first dose and the last doses, respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Androgenetic Alopecia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Primary safety and pharmacokinetic data
    Arm Type
    Experimental
    Arm Description
    To obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp
    Intervention Type
    Drug
    Intervention Name(s)
    Minoxidil
    Other Intervention Name(s)
    Latanoprost
    Intervention Description
    Topical formulation applied once a day.
    Primary Outcome Measure Information:
    Title
    Pharmacokinetic data: Cmax
    Description
    Individual and mean maximum plasma concentration (Cmax)
    Time Frame
    7 days
    Title
    Pharmacokinetic data: tmax
    Description
    Individual and mean tmax
    Time Frame
    7 days
    Title
    Pharmacokinetic data: Half-life (t1/2)
    Description
    Individual and mean half-life (t1/2)
    Time Frame
    7 days
    Title
    Pharmacokinetic data: AUC
    Description
    Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
    Time Frame
    7 days
    Title
    Pharmacokinetic data: Drug clearance
    Description
    Individual and mean apparent clearance of drug from plasma
    Time Frame
    7 days
    Title
    Safety : Skin TEAEs
    Description
    Incidence of treatment-emergent adverse events related to skin irritation at the administration site
    Time Frame
    7 days
    Title
    Safety: Systemic TEAEs
    Description
    Incident of systemic treatment-emergent adverse events
    Time Frame
    7 days
    Title
    Safety: Evaluation of QTs Interval Prolongation
    Description
    Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed
    Time Frame
    7 days

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males between age 18 to 65 years, in general good health. Good health is defined as a subject without any active diseases. Not included in active diseases are: Migraines Non-hospitalized depression o Asthma Cholecystectomy Gilbert's syndrome Clinical diagnosis of AGA with grade II to VI hair loss on Norwood Hamilton Classification System Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator's opinion, interfere with study assessments. No known allergy to ANR-001.1 or any of its components. Subject is willing to avoid extensive sun exposure, phototherapy, or use of tanning salon for the duration of the study. Exclusion Criteria: If subjects have a BMI outside of the range of 18-35kg/m2 Subjects using a minoxidil product (e.g., Rogaine or generic Rogaine) or a latanoprost product (e.g., Xalatan or generic Xalatan) within 30 days of the start of Day 1 of the study. Subjects whose vital signs, ECG, safety labs or physical exam results are clinically significant in the opinion of the investigator. Subjects have a skin condition that, in the Investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation. Subjects with an active or recent (within 30 days before Day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.). Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test treatment. Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia

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