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

Alopecia Areata Clinical Trial

Official title:

A First-in-Human Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-40070 in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05196711
• Other study ID #: MAX-40070-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2021
• Source: Maxinovel Pty., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: November 30, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• MAX-40070
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.
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maxinovel Pty., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum observed concentration (Cmax)	Pharmacokinetics	1 Day
Secondary	Time at which Cmax was first observed (Tmax)	Pharmacokinetics	1 Day
Secondary	Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)	Pharmacokinetics	1 Day
Secondary	Area under the concentration curve for on dosing interval at steady state (AUC0-t)	Pharmacokinetics	36 Days