A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Alopecia Areata
Age (in years)
18 - 55
Phase
Phase 1
Participants needed
78
Est. Completion Date
Nov 30, 2022
Treatment type
Interventional
Sponsor
Maxinovel Pty., Ltd.
ClinicalTrials.gov identifier
NCT05196711
Study number
MAX-40070-001
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