A Phase 1 interventional study of MAX-40070 and Placebo in Alopecia Areata, sponsored by Maxinovel Pty., Ltd.. Status unknown. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.
Sponsored by Maxinovel Pty., Ltd. · Phase 1, Interventional, and Treatment
This is a First-in-Human phase I study to evaluate the safety, tolerability and pharmacokinetic characteristics of MAX-40070 in Healthy SubjectThe study will be comprised of 2 parts; Part A and Part B. Part A will be conducted at NZCR, and Part B will be conducted at both NZCR and another site(s) in China (if required). Part A will include approximately 48 participants, and Part B will include approximately 30 participants.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's planned enrollment of 78 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Maxinovel Pty., Ltd. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
MAX-40070 is a liniment with two dose specification: 0.5%, 2% (Weight/Volume). In SAD phase, MAX-40070 will be applied once in each cohort, and there will be 6 cohorts. For the first 2 cohorts, 0.5% MAX-40070 will be used. For the rest 4 cohorts, 2% MAX-40070 will be used. In MAD phase, MAX-40070 2% will be applied once daily for consecutive 14 days in each cohort.
Drug: MAX-40070
Placebo is a liniment with two dose specification: 0.5%, 2% (Weight/Volume) to match with active drug in 2:1 manner ( 6 active: 2 placebo in each cohort).
Drug: Placebo
In the SAD phase, the proposed doses will be increased gradually. Each cohort will consist of 8 subjects, with 6 subjects randomly assigned to MAX-40070. During the MAD phase, the treatment will be administered once a day for 14 consecutive days.
In the SAD phase, the proposed doses will be increased gradually. Each cohort will consist of 8 subjects, with 2 subjects randomly assigned to placebo In the MAD phase, the treatment will be administered once a day for 14 consecutive days. Each cohort will consist of 10 subjects, with 2 subjects randomly assigned to placebo
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
Time frame: 36 Days
Maximum observed concentration (Cmax)
Pharmacokinetics
Time frame: 1 Day
Time at which Cmax was first observed (Tmax)
Pharmacokinetics
Time frame: 1 Day
Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
Pharmacokinetics
Time frame: 1 Day
Area under the concentration curve for on dosing interval at steady state (AUC0-t)
Pharmacokinetics
Time frame: 36 Days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Maxinovel Pty., Ltd.