None listed
Conditions
Brief summary
This is a first-in-human, multi-center, randomized, double blind, two-part single and multiple ascending dose study to assess the safety of SNT9465, and how this drug acts in the body in healthy volunteers. SNT9465 may be indicated for use in patients with Hypertrophic Scars, but a trial of the drug in healthy volunteers is needed before trials in patients with Hypertrophic Scars can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of SNT9465 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with Hypertrophic Scars.
Interventions
Approximately 32 participants will be enrolled into the study as per below:
Part A (SAD): Approximately 24 participants, enrolled into 1 of 3 SAD cohorts (n=8), randomized 3:1 to SNT-9465 or placebo.
Cohort A1 - 1.0mg (0.5%) Topical Application dosed on Day 1 only, will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision.
Cohort A2 - 4.0mg (2.0%) Topical Application dosed on Day 1 only will be applied to 10 cm2 treatment area with
Approximately 32 participants will be enrolled into the study as per below: Part A (SAD): Approximately 24 participants, enrolled into 1 of 3 SAD cohorts (n=8), randomized 3:1 to SNT-9465 or placebo. Cohort A1 - 1.0mg (0.5%) Topical Application dosed on Day 1 only, will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision. Cohort A2 - 4.0mg (2.0%) Topical Application dosed on Day 1 only will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision. Cohort A3 - 8.0mg (4.0%) Topical Application dosed on Day 1 only will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision. Part B (multiple dose): • Cohort B1: Approximately 8 participants, randomised 3:1 to SNT-9465 or placebo; Cohort B1 dose to be confirmed by Safety Review Committee (SRC) within 3 weeks of the A3 SRC decision. It will be a topical application daily for 28 days and will be applied to 10 cm2 treatment area within the left or right lateral thigh. Days 1,2,15 and 28 will be administered the clinic under supervision. The remaining days the patient will self administer at home with the guidance of stencil and patient diary.
Sponsors
Syntara Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following inclusion criteria to be eligible for this study: Part A and Cohort B1 1) Male or female aged between 18 and 60 years (inclusive) at the screening visit; 2) Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 (inclusive) at the screening visit; 3) Adequate venous access in the left or right arm to allow collection of a number of blood samples; 4) Fitzpatrick skin type I, II or III; 5) Male participants must agree to use highly effective methods of contraception from Day -1 through at least 90 days after the last administration of study product; 6) Women of childbearing potential (WOCBP) must be nonpregnant, nonlactating and agree to use highly effective methods of contraception from Day -1 through at least 30 days after the last administration of study product; 7) Male participants must refrain from sperm donation from Day -1 through at least 90 days after the last administration of study product. Female participants must refrain from donation of ova from Day -1 through to at least 30 days after the last administration of study product; 8) Screening and Day -1 laboratory evaluations (e.g., chemistry panel, complete blood count with differential, prothrombin time/activated partial thromboplastin time, urinalysis, C reactive protein, creatinine clearance), vital signs, and electrocardiogram must be within normal limits or judged to be not clinically significant by the Investigator; 9) Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions.
Exclusion criteria
Participants meeting any of the following exclusion criteria will not be eligible for this study: Exclusion Criteria Parts A and B: 1) Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin, or cardiovascular disease or any other condition, that, in the opinion of the Investigator, would jeopardise the safety of the participant or impact the validity of the study results; 2) Current acute skin condition (e.g. eczema, psoriasis, broken skin, wounds) or large tattoos, scars or excess hair at the study product application site. Normal hair coverage and small blemishes are acceptable at the discretion of the Investigator; 3) History of keloid scarring or hypertrophic scarring 4) History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease; 5) Presence of a currently healing wound, recent musculoskeletal injury, or currently healing fracture; 6) Has received or is anticipated to receive any prescription systemic or topical medication within 14 days or 5 half-lives, whichever is longer, prior to commencement of study product, or use of any over-the-counter, complementary, or alternative medicine within 48 hours prior to commencement of study product. Note: paracetamol up to 2 grams per day, intranasal and inhaled corticosteroids, killed and inactive vaccines, contraceptives, antihistamines, vitamins, and dietary supplements are permitted; 7) Positive screening test for hepatitis panel (HBcAb, HBsAg, anti-HCV) or human immunodeficiency virus (HIV). Positive anti-HCV antibody is allowed if HCV PCR is negative; 8) History of drug abuse in the 2 years prior to screening; 9) Part A and Cohort B1 only: Positive drugs of abuse test at screening or CRU check-in, or positive alcohol breath test at CRU check-in. Participants may undergo 1 repeat urine drug screen or alcohol breath test per time point at the discretion of the Investigator; 10) Receipt of blood donation, or loss or donation of blood equal to or greater than 450 mL, within 30 days prior to commencement of study product, or plasma donation within 14 days before commencement of study product; 11) Has received an experimental therapy within 30 days or 5 half-lives, whichever is longer, prior to commencement of study product; 12) Systemic infection, other than the common cold, in the 7 days prior to commencement of study product.
Outcome results
None listed