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

Maxinovel

Status and phase: Unknown; Phase 1

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: MAX-40070

Study type: Interventional

Funder types: Industry

Identifiers

NCT05196711

MAX-40070-001

Details and patient eligibility

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

78 participants in 2 patient groups, including a placebo group

MAX-40070

Experimental group

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.

Treatment:

Drug: MAX-40070

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo