A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects

NCT05196711 | Unknown Phase 1

• 1 other identifier: MAX-40070-001
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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.

  36 Days

Secondary Outcomes (4)

• Maximum observed concentration (Cmax)

  1 Day

• Time at which Cmax was first observed (Tmax)

  1 Day

• Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)

  1 Day

• Area under the concentration curve for on dosing interval at steady state (AUC0-t)

  36 Days

Study Arms (2)

MAX-40070

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

MAX-40070 DRUG

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.

MAX-40070

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weigh at least 50kg (females) or 55kg (males) and have a BMI between 20.0 kg/m2 - 30.0 kg/m2.
• Subjects having no ulceration, damage, sunburn, redness, rash, acne, folliculitis, pigmentation, uneven skin tone, excessive freckles on the skin of the target application area and fever.

You may not qualify if:

• An abnormality related to the comprehensive physical examination, laboratory test, 12-lead ECG, and other diagnostic tests and which is determined by the investigator as clinically significant (CS).
• A history of CS diseases of heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system.
• Intolerance to venipuncture for blood collection and/or having blood or needle phobia.

Sponsors & Collaborators

• Maxinovel Pty., Ltd.: lead

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 19, 2022
• Study Start: February 28, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 30, 2022
• Last Updated: January 19, 2022

Record last verified: 2021-12