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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MAX-40070

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.

Group Type EXPERIMENTAL

MAX-40070

Intervention Type 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.

Placebo

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes