Status:
UNKNOWN
A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects
Lead Sponsor:
Maxinovel Pty., Ltd.
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05196711
Start Date
February 28 2022
End Date
November 30 2022
Last Update
January 19 2022
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