A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of OLX72021 in Healthy Males with Androgenetic Alopecia.
- Conditions
- Androgenetic AlopeciaSkin - Dermatological conditionsSkin - Other skin conditions
- Registration Number
- ACTRN12623000117617
- Lead Sponsor
- OLIX AU PTY LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Generally healthy with the exception of those medical conditions allowed as per the inclusion/exclusion criteria
3. Adult males, 18 to 75 years of age (inclusive) at screening, with mild to severe AGA of Norwood-Hamilton Classification score of 3 vertex to 7 with no other aetiology of hair loss (e.g. alopecia areata, scarring alopecia, telogen effluvium)
4. Body mass index greater than or equal to 18.0 and less than or equal to 30.0 kg/m2, with a body weight (to 1 decimal place) greater than or equal to 50 kg at screening.
5. Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration and have a negative test for cotinine at the screening visit and on the day of treatment (Day 1).
6. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing at the timepoints indicated in the Schedules of Assessments including:
a. Physical examination without any clinically significant findings;
b. Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 mmHg (inclusive) after 5 minutes in supine (or semi-supine) position;
c. Heart rate (HR) in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine (or semi-supine) position;
d. Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive);
e. No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests;
f. Triplicate 12-lead ECG (taken after the volunteer has been supine (or semi-supine) for at least 10 minutes) with a QT interval corrected using the Fridericia method (QTcF) less than or equal to 450 msec and no clinically significant abnormalities.
7. If not surgically sterilised, must agree to:
a. Not donate sperm after signing consent, during the study, and at least 90 days after the last dose of study drug;
b. If engaging in sexual intercourse with a female partner who could become pregnant, use a condom in addition to having the female partner use a highly effective contraceptive method.
8. Have suitable venous access for blood sampling.
9. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions including:
a. Undergo 2 punch biopsies of the scalp during the study
b. Receive a small non-permanent scalp tattoo dot, which may be re-applied throughout the study
c. Maintain the same hair style and length as at the start of the study for the duration of the study
d. Avoid semi-permanent hair products (e.g., colour, texturisers, relaxers) for the duration of the study [NOTE: use of daily styling products (e.g., hair gel, mousse, styling spray) are permitted on non-study visit days]
e. Use non-medicated shampoo and conditioner for the duration of the study (or Sponsor-supplied shampoo and conditioner in place of regular shampoo and conditioner, for the duration of the study). NOTE: use of Sponsor-supplied conditioner is optional for participants who do not use conditioner
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant (participants with resolved childhood asthma may be included in the study).
2. Any of the following clinically significant disease:
a. uncontrolled chronic diseases other than AGA (e.g., diabetes mellitus, hypertension, liver disease)
b. thyroid disease (hyperthyroidism, hypothyroidism) (NOTE: history of controlled thyroid disease > 12 weeks prior to administration of study treatment is not exclusionary)
3. History of clinically significant heart disease (e.g., ischemic heart disease, arrhythmia) within 24 weeks prior to the start of study treatment
4. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
5. Any dermatological disorders of the scalp which might interfere with the application of investigational product (IP) or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis or scalp atrophy
6. History or clinical signs of keloids or hypertrophic scars
7. History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than AGA
8. History of surgical correction of hair loss on the scalp
9. History of hair transplants
10. Current use of an occlusive wig, hair extensions or hair weaves
11. Use of topical treatments (minoxidil, anti-androgens, platelet rich plasma [PRP] or other agents known to affect hair growth) or devices (e.g., laser light therapy), purposed to promote scalp hair growth, within 12 weeks prior to administration of study treatment (NOTE: use of cosmeceuticals is not exclusionary if used > 2 weeks prior to administration of study treatment)
12. Use of the following medications within 24 weeks prior to the first administration of study treatment:
a. Minoxidil
b. Dutasteride, finasteride
c. Androgenic agent (e.g., anabolic steroid)
d. Anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine, ketoconazole) (NOTE: topical use is not exclusionary if used > 12 weeks prior to administration of study treatment)
e. Medications that potentially cause hypotrichosis (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium, heparin, coumarin, carbamazepine, valproic acid, lithium)
f. Medications that potentially cause hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens, phenothiazines)
13. Anti-cancer agents, including cytotoxic agents, that can potentially have effects on alopecia within 12 months prior to the first administration of study treatment
14. Scalp hair loss on the treatment area, due to disease, injury or medical therapy
15. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
16. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
17. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
18. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method