Clinical trial NCT05864885: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Androgenetic Alopecia
Lead sponsor: Aneira Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DataPharm Australia, CMAX Clinical Research, Agilex Australia
First posted: 2023-05-18
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetic data: Cmax
timeFrame: 7 days
measure: Pharmacokinetic data: tmax
timeFrame: 7 days
measure: Pharmacokinetic data: Half-life (t1/2)
timeFrame: 7 days
measure: Pharmacokinetic data: AUC
timeFrame: 7 days
measure: Pharmacokinetic data: Drug clearance
timeFrame: 7 days
measure: Safety : Skin TEAEs
timeFrame: 7 days
measure: Safety: Systemic TEAEs
timeFrame: 7 days
measure: Safety: Evaluation of QTs Interval Prolongation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: