None listed
Conditions
Brief summary
This is a randomised, double-blind, placebo-controlled, single ascending dose treatment, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, OLX72021, in 5 cohorts. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. Healthy male volunteers with mild to severe androgenetic alopecia (AGA), aged 18 to 75 years of age (inclusive) at the time of screening are eligible for recruitment. The total maximum study duration for participants in this study is 87 days (approx. 12 weeks). This includes a screening period (Day -28 to Day -14) and 56 days (± 3 days) post-treatment follow-up. Androgenetic alopecia has been linked to an imbalance of androgen hormones. OLX72021 is designed to target the androgen receptor (AR) gene, leading to reduced AR protein expression in the body. Because androgenetic alopecia could be caused by an imbalance of androgens, blocking the AR gene helps to reduce these harmful responses and allow hair growth to return to normal. The information learned from this study may help future participants with androgenetic alopecia.
Interventions
This is a randomised, double-blind, placebo-controlled, single ascending dose treatment, multi-cohort study. Up to 30 healthy male volunteers with mild to severe androgenetic alopecia (AGA), aged 18 to 75 years of age (inclusive) at the time of screening will be enrolled in a total of 5 cohorts (Cohorts 1 to 5). The study will evaluate 5 dose levels of the investigational product, OLX72021, at the following dose levels:
• Cohort 1: 0.6 mg (0.1 mg/injection)
• Cohort 2: 3.0 mg (0.5 mg/injection)
This is a randomised, double-blind, placebo-controlled, single ascending dose treatment, multi-cohort study. Up to 30 healthy male volunteers with mild to severe androgenetic alopecia (AGA), aged 18 to 75 years of age (inclusive) at the time of screening will be enrolled in a total of 5 cohorts (Cohorts 1 to 5). The study will evaluate 5 dose levels of the investigational product, OLX72021, at the following dose levels: • Cohort 1: 0.6 mg (0.1 mg/injection) • Cohort 2: 3.0 mg (0.5 mg/injection) • Cohort 3: 6.0 mg (1.0 mg/injection) • Cohort 4: 7.2 mg (1.2 mg/injection) • Cohort 5: 9.0 mg (1.5 mg/injection) A single OLX72021 treatment will be administered as 6 intradermal injections to the scalp on study Day 1. Each dose level will be evaluated in a cohort of 6 participants with 4 participants receiving OLX72021 and 2 participants receiving placebo. Dosing in each cohort will start with 2 sentinel participants (1 participant will receive OLX72021 and the other will receive placebo). The safety and tolerability of each sentinel participant will be monitored until Day 2 prior to dosing the remainder of participants in each cohort. The clinical facility staff will administer the study drug via intradermal injections to participants. Compliance will be monitored by site staff witnessing of dosing and documentation in participant study file. Dosing compliance will be recorded in study-specific patient diaries recording the date, time and dose administered.
Sponsors
OLIX AU PTY LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration (prior use of nasal sprays for hayfever may be permitted at the discretion of the PI; use of inhaled steroids for asthma is not exclusionary). 19. Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants. 20. Estimated creatinine clearance (CrCl) < 60 mL/min/1.73m squared or serum creatinine more than 1.5-fold above the ULN. 21. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit. 22. History of substance abuse or alcohol abuse within 12 weeks prior to the screening visit (defined as more than an average of 14 standard drinks per week or regular consumption of more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]). 23. Positive drugs of abuse or alcohol breath test results at the screening visit or on the day of treatment (Day 1). 24. Use of any prescription or over-the-counter medication (including herbal products, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration – exceptions include occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days), ibuprofen (doses of 400 mg up to every 6 hours or 1.2 g per day maximum for no more than 3 consecutive days), topical ointments, and vitamins or dietary supplements. 25. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer’s ability to participate in the trial 26. Use of any vaccinations within 14 days prior to the first study drug administration. 27. Male participants with female partners of childbearing potential who are planning to become pregnant or do not agree to use one or more of the clinically appropriate methods of contraception from the first day of study participation until 90 days following the last administration of study treatment. 28. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration. 29. Treatment with an investigational drug in another clinical trial within 60 days or 5 half-lives of the other investigational drug (whichever is longer) prior to the first administration of study drug in this trial. 30. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
Outcome results
None listed