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

• ClinicalTrials.gov Identifier: NCT05864885
• Recruitment Status: Not yet recruiting
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Sponsor: Aneira Pharma, Inc.
• Collaborator: DataPharm Australia, CMAX Clinical Research, Agilex Australia
• Information provided by (Responsible Party): Aneira Pharma, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Drug: Minoxidil	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of Safety and Pharmacokinetics of Once-Daily Topical Solution in Male Subjects With Androgenetic Alopecia
• Estimated Study Start Date: June 9, 2023
• Estimated Primary Completion Date: July 17, 2023
• Estimated Study Completion Date: July 17, 2023

Arms and Interventions

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 Name: Latanoprost

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic data: Cmax [ Time Frame: 7 days ]
   Individual and mean maximum plasma concentration (Cmax)
2. Pharmacokinetic data: tmax [ Time Frame: 7 days ]
   Individual and mean tmax
3. Pharmacokinetic data: Half-life (t1/2) [ Time Frame: 7 days ]
   Individual and mean half-life (t1/2)
4. Pharmacokinetic data: AUC [ Time Frame: 7 days ]
   Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
5. Pharmacokinetic data: Drug clearance [ Time Frame: 7 days ]
   Individual and mean apparent clearance of drug from plasma
6. Safety : Skin TEAEs [ Time Frame: 7 days ]
   Incidence of treatment-emergent adverse events related to skin irritation at the administration site
7. Safety: Systemic TEAEs [ Time Frame: 7 days ]
   Incident of systemic treatment-emergent adverse events
8. Safety: Evaluation of QTs Interval Prolongation [ Time Frame: 7 days ]
   Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Aneira Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT05864885
• Other Study ID Numbers: ANR C002
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Antihypertensive Agents; Vasodilator Agents