Atopic DermatitisPhase 1NCT05843422
A First-in-Human Study of QY211 Gel in Adult Subjects
A Phase 1 study of Atopic Dermatitis, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ia/Ib,Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients with Mild to Moderate Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 23 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1
- Male or female subjects (male or female) aged 18-45 years (inclusive);
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 18.0 to 27.0 kg/m2 (including the cut-off value);
- the investigator determined vital signs, physical examination, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function, pregnancy test (female), hepatitis, HIV, syphilis), routine 12-lead ECG results in line with healthy subjects
- the subject fully understood the purpose, nature, methods and possible adverse reactions of the trial, volunteered to participate, and signed informed consent before the start of any study procedures;
- the subject was able to communicate well with the investigator, and understand and comply with the requirements of this study.
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- Part 2
- Male and female patients aged 18-65 years (including the boundary value);
- Meet Hanifin-Rajka diagnostic criteria at screening and have a history of AD for at least 6 months ;
- IGA score of 2 (mild) or 3 (moderate) at screening and baseline;
- The total area of atopic dermatitis lesions is 5% -20% BSA
- Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participate, and sign an informed consent form before the start of any study procedures;
- Patients can communicate well with the investigator and comply with the study and follow-up procedures;
Who cannot join
- Part 1
- Allergic constitution, such as allergic to two or more drugs and food; or known to be allergic to the composition of this drug (QY201 and excipients: carbomer (homopolymer type B 974P NF), edetate disodium, sodium hydroxide, propylene glycol and purified water);
- Patients who have received surgery within 3 months before screening, or plan to undergo surgery during the study period, or have received surgery that will affect drug absorption, distribution, metabolism and excretion;
- Previous or current cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, neurological, gastrointestinal system, metabolism and bone diseases, and the investigators believe that the subjects have clinical significance, not suitable for the trial;
- Patients who can not tolerate venipuncture, have a history of fainting needle, halo blood;
- History or presence of clinically relevant skin diseases that, in the opinion of the investigator, contraindicate the study or affect the assessment of the site of administration, including psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, other skin lesions, history of skin cancer, or skin diseases that affect the safety evaluation of the test drug;
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- Vaccination with live (attenuated) vaccines within 2 months prior to screening;
- Smoking or drinking within 3 months before screening (smoking: > 10 cigarettes/day; drinking: > 15 g pure alcohol/day, equivalent to 450 mL beer, 150 mL wine or 50 mL low-grade liquor), or alcohol and drug abuse (morphine/methylamphetamine/ketamine/methylenedioxyamphetamine/tetrahydrocannabinolic acid/cocaine) test positive;
- Participated in other drug or device clinical trials within 3 months before screening;
- Non-physiological blood loss ≥ 400 mL (including trauma, blood collection, blood donation) within 3 months before screening, or plan to donate blood during the study or within 1 month after the end of the study;
- Pregnant women, lactating women, or subjects who have plans to donate sperm or eggs, or (including male and female subjects) refuse to voluntarily take effective contraceptive measures from the screening period to 6 months after the end of the last dose;
- Use of any other drugs, including oral or topical drugs such as prescription drugs, over-the-counter drugs, and herbal medicines, except vitamins and/or paracetamol, within 2 weeks before screening;
- Drinking excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before screening;
- Subjects have skin conditions in the target application area (back, lateral arm area) that affect the tolerability assessment of the study, such as tattoos;
- Subjects who are judged unsuitable for participation by other investigators;
- Part 2
- Patients with or suspected active tuberculosis, latent untreated tuberculosis, incompletely cured tuberculosis or Mycobacterium tuberculosis infection (except for treatment records that prove that patients have been adequately treated, according to the medical judgment of the investigator and/or infectious disease experts, can enter this study) as judged by the investigator and/or infectious disease specialist (combined with medical history, symptoms, signs, laboratory tests, T-spot test, imaging examination);
- Hepatitis B surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV-Ab) positive during screening; or HIV antibody or Treponema pallidum antibody positive;
- Patients with any clinical symptoms of bacterial, viral, parasitic or fungal infection requiring treatment during the screening period;
- Previous disseminated herpes zoster (single attack), or disseminated herpes simplex (single attack), or recurrent (≥ 2 attacks) local herpes zoster;
- Patients with a history of mental illness or genetic history of mental illness or epilepsy, the use of antipsychotic drugs, sedative drugs;
- In addition to a history of atopic dermatitis, previous history of other connective tissue diseases, or severe cardiovascular, liver, kidney, digestive tract, nerve, skin and other diseases, or patients with malignant tumors (except completely removed cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma), systemic sex hormone therapy or other interventions may be required, and participation in this study may be at risk as judged by the investigator;
- Patients with non-immune factors (such as hyperlipidemia, diabetes, thyroid disease, severe heart abnormalities, etc.);
- Patients who have previously suffered from lymphatic diseases, or have signs or symptoms of lymphoproliferative diseases, including but not limited to lymph nodes or splenomegaly;
- In addition to atopic dermatitis, suffering from other skin diseases that affect the evaluation of the test results, or the presence of large tattoos, birthmarks, skin scars and other conditions in the skin lesions;
- Known immunodeficiency disease or first-degree relatives with hereditary immunodeficiency disease;
- Patients with cerebral hemorrhage or cerebral infarction within 1 year;
- Patients with previous thromboembolism (including deep venous thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism;
- Previous or planned organ transplantation (such as liver and kidney transplantation);
- Clinical or laboratory tests judged by the investigator as abnormal with clinical significance;
- History of alcoholism or drug abuse within 6 months before screening;
- Participated in any investigational drug 4 weeks (or 5 half-lives, whichever is longer) before screening or participated in any medical device clinical trial within 3 months;
- Non-physiological blood loss ≥ 400 mL (including trauma, blood sampling, blood donation) within 3 months before screening, or plan to donate blood during the study or within 1 month after the end of the study;
- Patients with the following cardiac abnormalities:
- Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting or coronary stent implantation within 3 months prior to screening;
- Severe arrhythmia (e.g., second-degree type 2 or third-degree atrioventricular block, long QT syndrome or QTcF abnormalities: male > 470 ms female > 480 ms, atrial fibrillation, frequent premature beats);
- Decompensated cardiac insufficiency (NYHA class III or IV);
- Other cardiac diseases requiring treatment and assessed by the investigator as inappropriate for participation in this study;
- Systemic or local use of JAK inhibitors (eg, Ruxolitinib, Tofacitinib, Baricitinib, Filgotinib, Lestaurtinib, Pacritinib, Delgocitinib, Upadacitinib, Abrocitinib, etc) within 3 months prior to screening;
- Major surgical procedures or serious trauma within 8 weeks prior to screening or anticipation of major surgical procedures during the trial (defined as major surgical procedures referring to Grade 3 and 4 procedures as specified in the Measures for the Management of Clinical Applications of Medical Technology implemented on November 1, 2018), and all surgical or major trauma-related AEs had not recovered (recovered to CTCAEv5.0 ≤ Grade 1 or baseline) before screening.
- Received biological therapy for atopic dermatitis (including but not limited to dupilumab) within 8 weeks (or 5 elimination half-lives, whichever is longer) before randomization;
- Received live (attenuated) vaccine within 4 weeks before randomization, or planned to receive live (attenuated) vaccine during treatment and within 4 weeks after the last use of investigational product;
- Patients who have used long-acting anticoagulants (such as warfarin, dabigatran, etc.) or need to continue anticoagulant therapy (except aspirin ≤ 100 mg/day) within 4 weeks before randomization;
- Receiving systemic therapy (including glucocorticoids, cyclosporine, mycophenolate mofetil, interferon γ, azathioprine, methotrexate, tripterygium wilfordii tablets and other Chinese herbal medicines) known or likely to affect atopic dermatitis within 4 weeks (or 5 half-lives, whichever is longer) before randomization, phototherapy (such as UVB, PUVA, etc.) or receiving antihistamines within 2 weeks before randomization;
- Patients who have received topical drugs known or likely to affect atopic dermatitis within 2 weeks before randomization, including but not limited to topical glucocorticoids (TCS), calcineurin inhibitors (TCI), topical phosphodiesterase 4 (PDE 4) inhibitors;
- Use of topical antibiotics, antibacterial soap, sodium hypochlorite in the target application area within 7 days before randomization, or use of emollients not provided by the sponsor or designated by the investigator within 12 hours before baseline;
- Allergic constitution or suspected allergy to the active ingredients or excipients of the investigational drug;
- Pregnant women, lactating women, or patients (including male and female patients) refuse to voluntarily take effective contraceptive measures during the screening period until 6 months after the end of the last dose (see Appendix 2 for details);
- Do not avoid prolonged exposure to natural or artificial ultraviolet (UV) radiation, or plan to perform such exposure during the study, and the investigator believes that it may affect atopic dermatitis;
- Any patient considered unsuitable for participation in this clinical study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
CuiYun Wu, 021-52888045, wucuiyun@fudan.edu.cn
Jing Zhang, Ph.D, M.D
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients With Mild to Moderate Atopic Dermatitis
This is a phase Ia/Ib,Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients with Mild to Moderate Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- 0.1% QY211 Gel or placebo, 0.3% QY211 Gel or placebo, 0.8% QY211 Gel or placebo, 1.5% QY211 Gel or placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% QY211 Gel or placeboDrug
QY211 Gel or placebo topical applied to skin
0.3% QY211 Gel or placeboDrug
QY211 Gel or placebo topical applied to skin
0.8% QY211 Gel or placeboDrug
QY211 Gel or placebo topical applied to skin
1.5% QY211 Gel or placeboDrug
QY211 Gel or placebo topical applied to skin
| Study group | Role | What they receive |
|---|---|---|
| part 1-0.8% QY211 Gel or placebo（10%BSA） | Experimental | 6 subjects use 0.8% QY211 Gel，2 subject uses 0.8% QY211 placebo ，11days（Day1 QD,Day4-Day10 BID,Day11 QD ）. Receives: Drug: 0.8% QY211 Gel or placebo |
| part 1-1.5% QY211 Gel or placebo（10%BSA） | Experimental | 6 subjects use 0.8% QY211 Gel，2 subject uses 0.8% QY211 placebo ，11days（Day1 QD,Day4-Day10 BID,Day11 QD ）. Receives: Drug: 1.5% QY211 Gel or placebo |
| part 1-1.5% QY211 Gel or placebo（20%BSA） | Experimental | 6 subjects use 0.8% QY211 Gel，2 subject uses 0.8% QY211 placebo ，11days（Day1 QD,Day4-D10 BID,Day11 QD ）. Receives: Drug: 1.5% QY211 Gel or placebo |
| part 2-0.1% QY211 Gel or placebo | Experimental | 6 subjects use 0.1% QY211 Gel，2 subject uses 0.1% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. Receives: Drug: 0.1% QY211 Gel or placebo |
| part 2-0.3% QY211 Gel or placebo | Experimental | 6 subjects use 0.3% QY211 Gel，2 subject uses 0.3% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. Receives: Drug: 0.3% QY211 Gel or placebo |
| part 2-0.8% QY211 Gel or placebo | Experimental | 6 subjects use 0.3% QY211 Gel，2 subject uses 0.3% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. Receives: Drug: 0.8% QY211 Gel or placebo |
| part 2-1.5% QY211 Gel or placebo | Experimental | 6 subjects use 0.3% QY211 Gel，2 subject uses 0.3% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. Receives: Drug: 1.5% QY211 Gel or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part1:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Day 1 to Day 13
Part1:Number of Participants With Clinical Laboratory Abnormalities
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug
Measured: Day 3 to Day 13
Part1:Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
Measured: Day 3 to Day 13
Part1:Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
ECG data will be monitored
Measured: Day 3 to Day 13
Part 1:Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
Measured: Day 1 to Day 13
Part 1:Severity of local skin irritation
Skin irritation response assessment recording method: ① subjective symptoms: including itching, pain, or burning sensation, evaluated according to the 4-level method: 0=none; 1=mild, without affecting daily life and sleep; 2=Moderate, affecting daily life but not sleep; 3=Severe, affecting sleep.The signs of skin lesions include erythema, papules, edema, blisters, bullae, exudates, pustules, erosion, exudates, ulcers, hypertrophy, desquamation, etc., which can be evaluated according to the 4-level method: 0=none; 1=Mild, with only blurred erythema, no edema (skin lesions not palpable), and papules; 2=Moderate, clear erythema with edema (skin lesions can be touched) and papules; "3=Severe, with blisters, bullae, exudates or pustules, erosion, exudates or ulcers.
Measured: Day 1 to Day 13
Part 2:Number of Participants With Adverse Events (AEs) and Serious Adverse Events
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Day 1 to Day 31
Part2:Number of Participants With Clinical Laboratory Abnormalities
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug
Measured: Day 8 to Day 29
Part2:Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
Measured: Day 8 to Day 29
Part2:Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
ECG data will be monitored
Measured: Day 8 to Day 29.
Part 2:Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
Measured: Day 8 to Day 30
Secondary outcomes (11)
Rate of change from baseline in Eczema Area and Severity Index (EASI) in patients（part 2 only）
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration /papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs ) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Measured: Up to 4 weeks
Proportion of patients with at least a 2-point improvement in IGA score from baseline（part 2 only）
The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).Proportion of patients with Investigator's Global Assessment (IGA) score of 0 or 1 and an improvement of at least 2 points in IGA score from baseline at 1, 2, 3 and 4 weeks after treatment.
Measured: Up to 4 weeks
Percentage of Participants Achieving >=50%/75%/90% Improvement From Baseline in Eczema Area and Severity Index (EASI-50/EASI-75/EASI-90) Response（part2 only）
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs ) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Measured: Up to 4 weeks
Change from baseline in Peak daily Pruritus NRS score (PP-NRS) （part 2 only）
Change from baseline in Peak daily Pruritus NRS score (PP-NRS) during treatment.Using a 0 to 10 point scale, 0 represents "" no itching "" and 10 represents "" worst itch imaginable ""，Rating the degree of itchiness experienced in the past 24 hours.
Measured: Up to 29 days
Rate of change from baseline in SCORAD score （part 2 only）
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b) 2 subjective symptom of pruritus (0-10 points) and sleep disturbance measured (0-10 points); and c) 6 disease intensity assessments [Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each grades from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103.
Measured: Up to 4 weeks
Change from baseline in total score of Dermal Quality of Life Index Questionnaire (DLQI) （part 2 only）
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
Measured: Up to 4 weeks
Rate of change from baseline in atopic dermatitis in BSA（part 2 only）
Rate of change from baseline in atopic dermatitis in BSA at Weeks 1, 2, 3, and 4 postdose.
Measured: Up to 4 weeks
Tmax of QY211-Single and Multiple Dose Drugs
Time of maximum concentration(single Dose and Steady state PK)
Measured: Up to 29 days
Cmax of QY211-Single and Multiple Dose Drugs
Maximum observed plasma concentration(single Dose and Steady state PK)
Measured: Up to 29 days
t1/2 of QY211-Single and Multiple Dose Drugs
The time it takes for the blood concentration of the drug to drop by half from the highest value in the body(single Dose and Steady state PK)
Measured: Up to 29 days
AUC QY211-Single and Multiple Dose Drugs
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration(single Dose and Steady state PK)
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Mar 2023
- Primary completion23 Oct 2024 (estimated)
- Study completion23 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843422
- Sponsor's protocol ID
- QY211-Ⅰ-1
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05843422
- Acronym / sponsor ID
- QY211-Ⅰ-1
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 23 Oct 2024 (estimated)
- Study completion
- 23 Oct 2024 (estimated)
- First posted
- 6 May 2023 (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 phase Ia/Ib,Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of QY211 Gel in Healthy Chinese Subjects and Patients with Mild to Moderate Atopic Dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| part 1-0.8% QY211 Gel or placebo（10%BSA） | Experimental | Drug: 0.8% QY211 Gel or placebo6 subjects use 0.8% QY211 Gel，2 subject uses 0.8% QY211 placebo ，11days（Day1 QD,Day4-Day10 BID,Day11 QD ）. |
| part 1-1.5% QY211 Gel or placebo（10%BSA） | Experimental | Drug: 1.5% QY211 Gel or placebo6 subjects use 0.8% QY211 Gel，2 subject uses 0.8% QY211 placebo ，11days（Day1 QD,Day4-Day10 BID,Day11 QD ）. |
| part 1-1.5% QY211 Gel or placebo（20%BSA） | Experimental | Drug: 1.5% QY211 Gel or placebo6 subjects use 0.8% QY211 Gel，2 subject uses 0.8% QY211 placebo ，11days（Day1 QD,Day4-D10 BID,Day11 QD ）. |
| part 2-0.1% QY211 Gel or placebo | Experimental | Drug: 0.1% QY211 Gel or placebo6 subjects use 0.1% QY211 Gel，2 subject uses 0.1% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. |
| part 2-0.3% QY211 Gel or placebo | Experimental | Drug: 0.3% QY211 Gel or placebo6 subjects use 0.3% QY211 Gel，2 subject uses 0.3% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. |
| part 2-0.8% QY211 Gel or placebo | Experimental | Drug: 0.8% QY211 Gel or placebo6 subjects use 0.3% QY211 Gel，2 subject uses 0.3% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. |
| part 2-1.5% QY211 Gel or placebo | Experimental | Drug: 1.5% QY211 Gel or placebo6 subjects use 0.3% QY211 Gel，2 subject uses 0.3% QY211 placebo ，29days（Day1-Day28 BID,Day29 QD）. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Part 1
- Male or female subjects (male or female) aged 18-45 years (inclusive);
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 18.0 to 27.0 kg/m2 (including the cut-off value);
- the investigator determined vital signs, physical examination, clinical laboratory test values (blood routine, urine routine, blood biochemistry, coagulation function, pregnancy test (female), hepatitis, HIV, syphilis), routine 12-lead ECG results in line with healthy subjects
- the subject fully understood the purpose, nature, methods and possible adverse reactions of the trial, volunteered to participate, and signed informed consent before the start of any study procedures;
Key exclusion criteria (50 listed)
- Part 1
- Allergic constitution, such as allergic to two or more drugs and food; or known to be allergic to the composition of this drug (QY201 and excipients: carbomer (homopolymer type B 974P NF), edetate disodium, sodium hydroxide, propylene glycol and purified water);
- Patients who have received surgery within 3 months before screening, or plan to undergo surgery during the study period, or have received surgery that will affect drug absorption, distribution, metabolism and excretion;
- Previous or current cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, neurological, gastrointestinal system, metabolism and bone diseases, and the investigators believe that the subjects have clinical significance, not suitable for the trial;
- Patients who can not tolerate venipuncture, have a history of fainting needle, halo blood;
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 |
|---|---|---|
| 0.1% QY211 Gel or placeboQY211 Gel or placebo topical applied to skin | Drug | part 2-0.1% QY211 Gel or placebo |
| 0.3% QY211 Gel or placeboQY211 Gel or placebo topical applied to skin | Drug | part 2-0.3% QY211 Gel or placebo |
| 0.8% QY211 Gel or placeboQY211 Gel or placebo topical applied to skin | Drug | part 1-0.8% QY211 Gel or placebo（10%BSA）, part 2-0.8% QY211 Gel or placebo |
| 1.5% QY211 Gel or placeboQY211 Gel or placebo topical applied to skin | Drug | part 1-1.5% QY211 Gel or placebo（10%BSA）, part 1-1.5% QY211 Gel or placebo（20%BSA）, part 2-1.5% QY211 Gel or placebo |
Primary outcome
Part1:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 13
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Part1:Number of Participants With Clinical Laboratory Abnormalities
Time frame: Day 3 to Day 13
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug
Part1:Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
Time frame: Day 3 to Day 13
Part1:Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
Time frame: Day 3 to Day 13
ECG data will be monitored
Part 1:Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
Time frame: Day 1 to Day 13
Part 1:Severity of local skin irritation
Time frame: Day 1 to Day 13
Skin irritation response assessment recording method: ① subjective symptoms: including itching, pain, or burning sensation, evaluated according to the 4-level method: 0=none; 1=mild, without affecting daily life and sleep; 2=Moderate, affecting daily life but not sleep; 3=Severe, affecting sleep.The signs of skin lesions include erythema, papules, edema, blisters, bullae, exudates, pustules, erosion, exudates, ulcers, hypertrophy, desquamation, etc., which can be evaluated according to the 4-level method: 0=none; 1=Mild, with only blurred erythema, no edema (skin lesions not palpable), and papules; 2=Moderate, clear erythema with edema (skin lesions can be touched) and papules; "3=Severe, with blisters, bullae, exudates or pustules, erosion, exudates or ulcers.
Part 2:Number of Participants With Adverse Events (AEs) and Serious Adverse Events
Time frame: Day 1 to Day 31
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Part2:Number of Participants With Clinical Laboratory Abnormalities
Time frame: Day 8 to Day 29
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug
Part2:Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination
Time frame: Day 8 to Day 29
Part2:Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings
Time frame: Day 8 to Day 29.
ECG data will be monitored
Part 2:Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs
Time frame: Day 8 to Day 30
11 secondary outcomes
Rate of change from baseline in Eczema Area and Severity Index (EASI) in patients（part 2 only）
Time frame: Up to 4 weeks
Proportion of patients with at least a 2-point improvement in IGA score from baseline（part 2 only）
Time frame: Up to 4 weeks
Percentage of Participants Achieving >=50%/75%/90% Improvement From Baseline in Eczema Area and Severity Index (EASI-50/EASI-75/EASI-90) Response（part2 only）
Time frame: Up to 4 weeks
Change from baseline in Peak daily Pruritus NRS score (PP-NRS) （part 2 only）
Time frame: Up to 29 days
Rate of change from baseline in SCORAD score （part 2 only）
Time frame: Up to 4 weeks
Change from baseline in total score of Dermal Quality of Life Index Questionnaire (DLQI) （part 2 only）
Time frame: Up to 4 weeks
Rate of change from baseline in atopic dermatitis in BSA（part 2 only）
Time frame: Up to 4 weeks
Tmax of QY211-Single and Multiple Dose Drugs
Time frame: Up to 29 days
Cmax of QY211-Single and Multiple Dose Drugs
Time frame: Up to 29 days
t1/2 of QY211-Single and Multiple Dose Drugs
Time frame: Up to 29 days
AUC QY211-Single and Multiple Dose Drugs
Time frame: Up to 29 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Atopic Dermatitis, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
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 13 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jing Zhang, Ph.D, M.D (021-52888045, zhangj_fudan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part1:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1 to Day 13). The study lists 11 primary outcomes in all. 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 6 May 2023.