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

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Alopecia areata
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Brief Title

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

Official Title

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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments

Secondary Outcome

 Maximum observed concentration (Cmax)

Condition

Alopecia Areata

Intervention

MAX-40070

Study Arms / Comparison Groups

 MAX-40070
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

78

Start Date

February 28, 2022

Completion Date

November 30, 2022

Primary Completion Date

November 2, 2022

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Administrative Informations

NCT ID

NCT05196711

Organization ID

MAX-40070-001

Responsible Party

Sponsor

Study Sponsor

Maxinovel Pty., Ltd.

Study Sponsor

, ,

Verification Date

December 2021