None listed
Conditions
Brief summary
Androgenetic Alopecia (AGA) which is also known as male patern baldness is a common form of hair loss in both men and women. Samumed Company is developing SM04554 for the treatment of AGA. SM04554 is a small molecule which activates proteins involved in maintaining hair growth The purpose of this study is to learn more about the safety and activity of a SM04554. This study drug is a solution to be rubbed onto the scalp once every day for 14 days. To obtain information on the how the body absorbs distributes and removes the drug form the body (pharmacokinetics), blood samples will be taken to measure the concentration of the study drug over the 14 days of application. This study will also check safety by measuring heart, liver and kidney function, number of blood cells, vital signs and scalp assessments.
Interventions
Daily topical application of 0.25% (w/v) solution of SM04554 to scalp for 14 days.
SM04554 is supplied as in a non-aqueous solution of PEG400 at concentration of 0.25% weight per volume (w/v);1 vial of 0.5mL
Subject will apply at least 0.3mL of a 0.5mL study drug (SM04554) at site during visits under supervision of site staff.
Sponsors
Samumed Pacific Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Males with clinical diagnosis of AGA with Norwood classification score of 5, 5A, 5V or 6 Wiling to maintain hairstyle, use indicated shampoo & conditioner and not use semi-permanent hair products Willing to inform female partners to avoid direct contact as potential effects to a foetus is unknown Able to understand and willing to sign informed consent form
Exclusion criteria
Clinical diagnosis alopecia areata or other non-AGA forms of alopecia Scalp hair loss on treatment area due to disease, injury or medical therapy Current skin disease on treatment area or hands History of surgical correction for hair loss on scalp and or hair transplant Use of any products or devices clinically proven to promote hair loss within 24 weeks prior to Screening visit Use of anti-androgenic therapies within 12 weeks prior to Screening visit Previous exposure to SM04554 Use of semi-permanent hair products with 30 days prior to screening Use medicated shampoo&conditioner or OTC hair treatments of dandruff or promotion of hair growth within 30 days prior to screening Current use of an occlusive wig, hair extensions or hair weaves History of hypersensitivity or allergies to any ingredient of study drug Poor peripheral venous access History clinically significant cardiac arrhythmia Unwilling to refrain form sperm donations Participation in another drug or device clinical study within 30 days or 5 half lives of the investigational agent prior to screening Subjects with pregnant partners at screening visit
Outcome results
None listed