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Atopic DermatitisPhase 1NCT04815148

MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis

A Phase 1 study testing MH004 Ia(0.1%), MH004 Ia(0.3%) and MH004 Ia(1%) in people with Atopic Dermatitis and Rheumatoid Arthritis, run by Minghui Pharmaceutical Pty Ltd.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase Ia/Ib Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis and participants with Mild to Moderate Rheumatoid Arthritis. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis, Rheumatoid Arthritis
What is being tested?
MH004 Ia(0.1%), MH004 Ia(0.3%) and MH004 Ia(1%)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
No sites listed yet
Study dates
1 Apr 2021to 31 Mar 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Phase Ia and Ib:
  • Phase Ia: Adults, age 18 - 45 years old, inclusive, at time of screening. Phase Ib: Adults, age 18 - 70 years old, inclusive, at time of screening.
  • Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol.
  • Participants whose body mass index (BMI) at screening is within a range of ≥ 18.5 kg/m2 and <35 kg/m2.
  • (BMI = Body Weight (kg) / [Height (m) × Height (m)])
  • Has abstained from smoking or use of tobacco products from 6 months prior to study drug administration and for the entire duration of the study.
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  • Participant's medical history shows no contraindication to JAK inhibitors.
  • Participants judged to be in good health by the Investigator based upon the results of physical examinations (PEs), 12-lead electrocardiogram (ECG) test, and all items of routine laboratory tests, including serum biochemistry, hematology and urinalysis, are within normal range, or if outside normal range they are deemed not clinically significant as judged by the Investigator. Assessment items of blood biochemistry include albumin, total protein, total bilirubin, ALP, SGOT, SGPT, BUN, serum creatinine, CK and fasting lipid profile (total cholesterol, LDL, HDL and triglycerides). Assessment items of hematology tests include RBC count, WBC with differential counts, hemoglobin, hematocrit and platelet count. Assessment items of urinalysis include pH, colour, appearance, gravity, erythrocyte, leukocyte, glucose, protein, ketones and nitrite.
  • For the ECG test, QTcF must be ≤450msec for females or males, and PR interval <120msec and no evidence of bundle branch block.
  • Willingness of men and women of reproductive potential to observe conventional and highly effective birth control from the beginning of the study screening until 6 months after receiving the last treatment of investigational product. A highly effective method of contraception is defined as follows:
  • Highly Effective Methods That Have Low User Dependency
  • Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
  • Intrauterine device (IUD).
  • Intrauterine hormone-releasing system (IUS).
  • Bilateral tubal occlusion.
  • Vasectomized partner (is a highly effective contraceptive method provided that the partner is the sole sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used. The spermatogenesis cycle is approximately 90 days.
  • Highly Effective Methods That Are User Dependent (must be used in combination with a male or female condom)
  • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal, injectable.
  • Progestogen-only hormone contraception associated with inhibition of ovulation: oral, injectable.
  • WOCBP must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study.
  • Males must not donate sperm for at least 90 days after the last dose of study drug.
  • Participants are a current non-smoker (and has not smoked in the 6 months prior to baseline) and will not smoke throughout the course of the study. Screening cotinine test must be negative.
  • Additional Inclusion criteria for Phase Ib (Study 2-1, AD participants):
  • Participants who are diagnosed with mild to moderate atopic dermatitis for ≥3 months prior to screening based on the Hanifin and Rajka Criteria. Mild to moderate AD is defined as BSA 2-20%; EASI 3-16; IGA 2 - 3 at both the screening and Day 1 visit.
  • Participants with a Target Area of Atopic Dermatitis of approx. 10 x 10cm on any part of the body other than the scalp, face, palms of hands, soles of feet, buttocks or groin to apply the Study Drug. The Target Lesion Area score needs to be between mild (2) to moderate (3) on the Disease Affected Eczema Area and Severity Indices (EASI) at screening and Day 1.
  • Participant is able to apply the study drug to the Target Lesion Area; or if the Target Lesion is not easily reached (i.e. on their back), has someone who is willing and able to apply the study drug as prescribed during the treatment period.
  • Participants who agree to discontinue all treatment used for their AD, such as topical antihistamines, topical antimicrobials, topical or oral corticosteroid, systemic immune modulating agents and light treatments, as well as bleach baths and avoid prolonged sun exposure during the study period for/on the affected site(s) (except the standard medication oral antihistamine levocetirizine and rescue medication prescribed by the study Investigator(s)). Participants who are taking oral antihistamines need to be on a stable dose for at least 2 months.
  • Participants are required to stop using prohibited topical treatments for at least 14 days before the first investigational drug dose administration (or longer if the treatment half-life requires so 5 half-lives should have elapsed) and prohibited systemic treatment drugs for 28 days before the first investigational drug dose administration (or longer if the treatment half-life requires so 5 half-lives should have elapsed).
  • Additional Inclusion criteria for Phase Ib (Study 2-2, RA participants):
  • Diagnosed with Rheumatoid arthritis (RA) prior to screening who fulfil the 2010 ACR/EULAR classification for RA.
  • Mild to moderate disease activity at screening (DAS 28-CRP ≤ 4.5 and ≥ 2.6).
  • Active RA in one Target Joint of either hand or wrist at screening and baseline where both swelling and tenderness/pain is present.

Who cannot join

  • Phase Ia and Ib:
  • Participants with conditions at the study drug application site(s) that would interfere with the study drug administration, skin assessment, or reaction to study drug.
  • For example: presence of open sores; obvious differences in skin color between applications sites/discolouration such as vitiligo; excessive hair; scar tissue; tattoo.
  • Participants with any unstable health status, defined as having newly diagnosed medical conditions or symptoms of a medical condition that is not yet diagnosed within 30 days prior to the first dose of the study drug.
  • Healthy participants and RA participants only (i.e. does not apply to AD participants): Participants with any diagnosed dermatological condition within 180 days prior to the first study dose.
  • History of anaphylaxis.
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  • Participants with any clinically significant (as judged by the Investigator) hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder.
  • Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
  • Participants with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of the study medication.
  • This includes a screening eGFR <60mL/min/1.73m2 or screening transaminases > 1.5 x ULN.
  • Participant had participated in any investigational drug trial and took any investigational drug within 60 days prior to the first study dose.
  • Participant had blood donation of more than 250 mL within 60 days or 500 mL within 90 days prior to the first study drug dose.
  • Participant has current drug abuse or alcohol abuse per Investigator judgement. Participants must have a negative drug and alcohol test at screening and day 1.
  • Participants who are inappropriate to participate in this study, as judged by the Investigator.
  • Participants with any history of or current unstable mental health condition or any lifetime history of suicidal behaviour, as per Investigator judgement.
  • Participants who have known hypersensitivity to the study medication.
  • Participants who are pregnant or breast-feeding or intend to become pregnant during the course of the treatment and follow-up periods.
  • Any history of malignancy of any organ system (other than cervical carcinoma in situ or non-melanoma skin cancers that have been excised) within 5 years prior to study entry.
  • Major surgery (including joint surgery) within 8 weeks prior to screening or during the course of the study.
  • Known active current, or recent history within 3 months, requiring treatment of bacterial, viral, fungal, mycobacterial or other infections.
  • Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or up until the follow-up visit.
  • A history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
  • Any history of any blood clots or clotting disorders (e.g. Deep Vein Thrombosis, Pulmonary Embolism, coagulopathy).
  • Any known immunodeficiency disorder.
  • Mycobacterium tuberculosis (TB) infection as follows:
  • A positive QuantiFERON TB test within the 12 weeks prior to screening or during screening.
  • Any chest imaging (e.g. x-ray, CT) taken at screening or within the 12 weeks prior to screening with changes suggestive of active TB.
  • Been treated or is currently being treated for active or latent TB infection.
  • A history of either untreated or inadequately treated latent or active TB infection.
  • Participants with an indeterminate QuantiFERON TB test can have the test repeated and if a negative result is obtained, enrollment may proceed. If the repeat is indeterminate again, the participant will be excluded.
  • Participants who have been tested positive for the following tests:
  • Human immunodeficiency virus (HIV)
  • Hepatitis B virus (HBV): HBsAg or anti-HBc
  • Hepatitis C virus (HCV)
  • Additional exclusion criteria for Phase Ib (Study 2-1, AD participants):
  • Participants with active forms of dermatological conditions such as contact dermatitis, seborrheic, discoid, gravitational, asteatotic and dyshidrotic eczema) or other inflammatory skin diseases that are not AD, such as psoriasis, viral infection, fungal infection or bacterial infection.
  • Participants who are inevitable to engage in activities involving excessive or prolonged exposure to sunlight.
  • Treatment with a biologic agent or JAK inhibitor at any time prior to baseline.
  • Additional exclusion criteria Phase Ib (Study 2-2, RA participants):
  • Rheumatic autoimmune disease other than rheumatoid arthritis.
  • Functional class IV American College of Rheumatology (ACR) Classification.
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondylarthritis, reactive arthritis, overlap connective tissue disease). History of secondary Sjogren's syndrome is permitted.
  • Treatment with a biologic agent or JAK inhibitor at any time prior to baseline.
  • Note:
  • Treatment with traditional DMARDs is allowed provided that the dose is stable for ≥3 months prior to baseline.
  • Oral corticosteroids (e.g. Prednisolone) are allowed if the dose is ≤10mg per day and has been stable for two weeks prior to baseline.
  • NSAIDs and other low-potency analgesics are allowed if the dose has been stable for two weeks prior to baseline. High potency analgesics are excluded.
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline.
  • Previous treatment with tocilizumab.
  • History of or currently active primary or secondary immunodeficiency.

About this study

Official title: A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and PK of MH004 Topical Cream in Healthy Adult Volunteers and to Investigate Its Efficacy and Safety Profile in Participants With Atopic Dermatitis or Rheumatoid Arthritis

This is a Phase Ia/Ib Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis and participants with Mild to Moderate Rheumatoid Arthritis.

Read the detailed description

The study includes 2 parts:The first part (Phase Ia) is a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy volunteers. The second part (Phase Ib) includes two randomised, Placebo-Controlled 28-day repeated dose studies for AD and RA participants respectively, using defined concentrations of the topical cream based on the PK and safety data in healthy volunteers in Phase Ia.

Being tested
MH004 Ia(0.1%), MH004 Ia(0.3%), MH004 Ia(1%), MH004 Ia(3%), MH004 Ib-1(0.1%)
Medical subject headings
Dermatitis, Atopic, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MH004 Ia(0.1%)Drug

    Also called MH004 Topical Cream

    Spread approx. 1 g of MH004 topical cream to the upper thigh skin.

  • MH004 Ia(0.3%)Drug

    Also called MH004 Topical Cream

    Spread approx. 1 g of MH004 topical cream to the upper thigh skin.

  • MH004 Ia(1%)Drug

    Also called MH004 Topical Cream

    Spread approx. 1 g of MH004 topical cream to the upper thigh skin.

  • MH004 Ia(3%)Drug

    Also called MH004 Topical Cream

    Spread approx. 1 g of MH004 topical cream to the upper thigh skin.

  • MH004 Ib-1(0.1%)Drug

    Also called MH004 Topical Cream

    Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.

  • MH004 Ib-1(0.3%)Drug

    Also called MH004 Topical Cream

    Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.

  • MH004 Ib-1(1%)Drug

    Also called MH004 Topical Cream

    Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.

  • MH004 Ib-2(0.3%)Drug

    Also called MH004 Topical Cream

    Spread approx. 0.5 g of MH004 topical cream to the Target Joint.

  • MH004 Ib-2(1%)Drug

    Also called MH004 Topical Cream

    Spread approx. 0.5 g of MH004 topical cream to the Target Joint.

  • MH004 Ib-2(3%)Drug

    Also called MH004 Topical Cream

    Spread approx. 0.5 g of MH004 topical cream to the Target Joint.

Study groups in NCT04815148
Study groupRoleWhat they receive
Phase Ia: MH004 (0.1%) in healthy volunteersExperimentalSAD and MAD
Receives: Drug: MH004 Ia(0.1%)
Phase Ia: MH004 (0.3%) in healthy volunteersExperimentalSAD and MAD
Receives: Drug: MH004 Ia(0.3%)
Phase Ia: MH004 (1%) in healthy volunteersExperimentalSAD and MAD
Receives: Drug: MH004 Ia(1%)
Phase Ia: MH004 (3%) in healthy volunteersExperimentalSAD and MAD
Receives: Drug: MH004 Ia(3%)
Phase Ib-1: MH004 (0.1%) in Atopic DermatitisExperimental28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
Receives: Drug: MH004 Ib-1(0.1%)
Phase Ib-1: MH004 (0.3%) in Atopic DermatitisExperimental28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
Receives: Drug: MH004 Ib-1(0.3%)
Phase Ib-1: MH004 (1%) in Atopic DermatitisExperimental28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis
Receives: Drug: MH004 Ib-1(1%)
Phase Ib-2: MH004 (0.3%) in Rheumatoid ArthritisExperimental28-Day Repeated Dosing in Participants with Mild to Moderate Rheumatoid Arthritis
Receives: Drug: MH004 Ib-2(0.3%)
Phase Ib-2: MH004 (1%) in Rheumatoid ArthritisExperimental28-Day Repeated Dosing in Participants with Mild to Moderate Rheumatoid Arthritis
Receives: Drug: MH004 Ib-2(1%)
Phase Ib-2: MH004 (3%) in Rheumatoid ArthritisExperimental28-Day Repeated Dosing in Participants with Mild to Moderate Rheumatoid Arthritis
Receives: Drug: MH004 Ib-2(3%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].

    Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 The incidence, nature, and severity of AEs/SAEs including relationship to study treatment from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.

    The incidence, nature, and severity of AEs/SAEs leading to treatment discontinuation from MAD initial study drug administration time of randomisation until Day 7 for MAD participants.

    Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from initial study drug administration time of randomisation until Day 7 for SAD participants.

    Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.

    Measured: 1 year

  2. To determine the maximum tolerated dose (MTD) of MH004 topical cream.

    The determination of the maximum tolerated dose for phase 2.

    Measured: 1 year

  3. To establish the recommended phase 2 dose (RP2D).

    The determination of RP2D for phase 2 according to the result of dose expansion

    Measured: 1 year

Secondary outcomes (6)

  1. Characterization of Pharmacokinetics (Cmax)

    Maximum drug concentration (Cmax)

    Measured: Up to 6 Months

  2. Characterization of Pharmacokinetics (AUC)

    Area Under the Curve (AUC)

    Measured: Up to 6 Months

  3. Characterization of Pharmacokinetics (CL)

    Clearance (CL)

    Measured: Up to 6 Months

  4. Characterization of Pharmacokinetics (t1/2)

    Elimination half-life (t1/2)

    Measured: Up to 6 Months

  5. Change from baseline Target Lesion EASI score

    Percentage of Participants Achieving EASI50，EASI75，EASI90 from Baseline. The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score. The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.

    Measured: 1 year

  6. Change from baseline Target Joint swelling and tenderness score

    Change from baseline Target Joint swelling and tenderness score by visual anabg scale（VAS）on Day7, Day14 and Day 28 in participants with mild to moderaterheumatoid arthritis.The VAS score runs from 0 to 10, with higher scores indicating worse outcome

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start1 Apr 2021 (estimated)
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion31 Mar 2022 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04815148
Sponsor's protocol ID
MH004-CP001EN
Status last verified
Mar 2021
First submitted
19 Mar 2021
Last updated
24 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MH004 Ia(0.1%), MH004 Ia(0.3%) and MH004 Ia(1%) in people with Atopic Dermatitis and Rheumatoid Arthritis, run by Minghui Pharmaceutical 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 32 inclusion and 50 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 24 Mar 2021. 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. 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?

To evaluate the incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04815148.

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 24 Mar 2021.

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