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Alopecia Areata

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

Sponsored by Maxinovel Pty., Ltd.

About this trial

Last updated 4 years ago

Study ID

MAX-40070-001

Status

Not yet recruiting

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.