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

NCT05864885 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: ANR C002
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Primary safety and pharmacokinetic data

EXPERIMENTAL

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

Interventions

Minoxidil DRUG

Topical formulation applied once a day.

Also known as: Latanoprost

Primary safety and pharmacokinetic data

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aneira Pharma, Inc.: lead
• DataPharm Australia, CMAX Clinical Research, Agilex Australia: collaborator

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Latanoprost

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 18, 2023
• Study Start: June 9, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share