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

Phase I Study of Safety and Pharmacokinetics of Once-Daily Topical Solution in Male Subjects With Androgenetic Alopecia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: Minoxidil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary safety and pharmacokinetic data; To obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp	Drug: Minoxidil; Topical formulation applied once a day.; Other Names: Latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic data: Cmax	Individual and mean maximum plasma concentration (Cmax)	7 days
Pharmacokinetic data: tmax	Individual and mean tmax	7 days
Pharmacokinetic data: Half-life (t1/2)	Individual and mean half-life (t1/2)	7 days
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)	7 days
Pharmacokinetic data: Drug clearance	Individual and mean apparent clearance of drug from plasma	7 days
Safety : Skin TEAEs	Incidence of treatment-emergent adverse events related to skin irritation at the administration site	7 days
Safety: Systemic TEAEs	Incident of systemic treatment-emergent adverse events	7 days
Safety: Evaluation of QTs Interval Prolongation	Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed	7 days

Collaborators and Investigators

• Sponsor: Aneira Pharma, Inc.
• Collaborators: DataPharm Australia, CMAX Clinical Research, Agilex Australia

Study record dates

Study Major Dates

• Study Start (Anticipated): June 9, 2023
• Primary Completion (Anticipated): July 17, 2023
• Study Completion (Anticipated): July 17, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost; Minoxidil
• Other Study ID Numbers: ANR C002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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