A First-in-Human Study of QY211 Gel in Adult Subjects

NCT05843422 | Unknown Phase 1

• 1 other identifier: QY211-Ⅰ-1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (11)

• 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.

  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

  Day 3 to Day 13

• Part1:Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination

  Day 3 to Day 13

• Part1:Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings

  ECG data will be monitored

  Day 3 to Day 13

• Part 1:Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs

  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.

  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.

  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

  Day 8 to Day 29

• Part2:Number of Participants With Clinically Significant Changes Form Baseline in Physical Examination

  Day 8 to Day 29

• Part2:Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings

  ECG data will be monitored

  Day 8 to Day 29.

• Part 2:Number of Participants With Clinically Significant Changes Form Baseline in Vital Signs

  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）

  Up to 4 weeks

• Proportion of patients with at least a 2-point improvement in IGA score from baseline（part 2 only）

  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）

  Up to 4 weeks

• Change from baseline in Peak daily Pruritus NRS score (PP-NRS) （part 2 only）

  Up to 29 days

• Rate of change from baseline in SCORAD score （part 2 only）

  Up to 4 weeks

Study Arms (7)

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 ）.

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 ）.

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 ）.

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）.

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）.

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）.

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）.

Drug: 1.5% QY211 Gel or placebo

Interventions

0.1% QY211 Gel or placebo DRUG

QY211 Gel or placebo topical applied to skin

part 2-0.1% QY211 Gel or placebo

0.3% QY211 Gel or placebo DRUG

QY211 Gel or placebo topical applied to skin

part 2-0.3% QY211 Gel or placebo

0.8% QY211 Gel or placebo DRUG

QY211 Gel or placebo topical applied to skin

part 1-0.8% QY211 Gel or placebo（10%BSA）; part 2-0.8% QY211 Gel or placebo

1.5% QY211 Gel or placebo DRUG

QY211 Gel or placebo topical applied to skin

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Jing Zhang, Ph.D, M.D

CONTACT

021-52888045; zhangj_fudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 6, 2023
• Study Start: March 1, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)