Alopecia AreataPhase 1NCT05196711
A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects
A Phase 1 study testing MAX-40070 in people with Alopecia Areata, run by Maxinovel Pty., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- MAX-40070
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2022to 30 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A First-in-Human Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-40070 in Healthy Subjects
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.
- Conditions
- Alopecia Areata
- Being tested
- MAX-40070, Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-40070Drug
In the SAD phase, the proposed doses will be increased gradually. Each cohort will consist of 8 subjects, with 6 subjects randomly assigned to MAX-40070.
During the MAD phase, the treatment will be administered once a day for 14 consecutive days.
PlaceboDrug
In the SAD phase, the proposed doses will be increased gradually. Each cohort will consist of 8 subjects, with 2 subjects randomly assigned to placebo
In the MAD phase, the treatment will be administered once a day for 14 consecutive days. Each cohort will consist of 10 subjects, with 2 subjects randomly assigned to placebo
| Study group | Role | What they receive |
|---|---|---|
| MAX-40070 | Experimental | 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. Receives: Drug: MAX-40070 |
| Placebo | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
Measured: 36 Days
Secondary outcomes (4)
Maximum observed concentration (Cmax)
Pharmacokinetics
Measured: 1 Day
Time at which Cmax was first observed (Tmax)
Pharmacokinetics
Measured: 1 Day
Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
Pharmacokinetics
Measured: 1 Day
Area under the concentration curve for on dosing interval at steady state (AUC0-t)
Pharmacokinetics
Measured: 36 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start28 Feb 2022 (estimated)
- Primary completion2 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196711
- Sponsor's protocol ID
- MAX-40070-001
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-40070 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05196711
- Acronym / sponsor ID
- MAX-40070-001
- Conditions
- Alopecia Areata
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 2 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAX-40070 | Experimental | Drug: MAX-40070MAX-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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAX-40070In the SAD phase, the proposed doses will be increased gradually. Each cohort will consist of 8 subjects, with 6 subjects randomly assigned to MAX-40070. During the MAD phase, the treatment will be administered once a day for 14 consecutive days. | Drug | MAX-40070 |
| PlaceboIn the SAD phase, the proposed doses will be increased gradually. Each cohort will consist of 8 subjects, with 2 subjects randomly assigned to placebo In the MAD phase, the treatment will be administered once a day for 14 consecutive days. Each cohort will consist of 10 subjects, with 2 subjects randomly assigned to placebo | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
Time frame: 36 Days
skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
4 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: 1 Day
Time at which Cmax was first observed (Tmax)
Time frame: 1 Day
Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
Time frame: 1 Day
Area under the concentration curve for on dosing interval at steady state (AUC0-t)
Time frame: 36 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAX-40070 in people with Alopecia Areata, run by Maxinovel Pty., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments (time frame: 36 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.