Induced Pluripotent Stem Cell Derived Exosomes for the Treatment of Atopic Dermatitis

NCT05969717 | Unknown Early Phase 1

• 1 other identifier: K3016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety, tolerability, and preliminary efficacy of GD-iExo-001 in the treatment of atopic dermatitis

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• adverse events as assessed by CTCAE

  all potentially treated subjects to assess the safety

  42 days from post-administration

Secondary Outcomes (7)

• The proportion of subjects whose IGA score improved by 2 points or more compared with the baseline score.

  Screening, after the first administration 8 day, 15 days, 21 days, 42 days

• The proportion of subjects with an IGA score of 0-1 and an improvement of 2 or more over the baseline score

  Screening, after the first administration 8 day, 15 days, 21 days, 42 days

• The proportion of subjects whose EASI score improved by more than 50% compared with the baseline period

  Screening, after the first administration 8 day, 15 days, 21 days, 42 days

• The proportion of subjects whose EASI score improved by more than 75% compared with the baseline period

  Screening, after the first administration 8 day, 15 days, 21 days, 42 days

• The proportion of subjects whose EASI score improved by more than 90% compared with the baseline period

  Screening, after the first administration 8 day, 15 days, 21 days, 42 days

Study Arms (2)

GD-iExo-001 treatment

EXPERIMENTAL

Group1 (low-dose group), 8 papatients are treated with 10 μg/mL GD-iExo-001. Group2 (high-dose group), 8 papatients are treated with 50 μg/mL GD-iExo-001. One drop (about 50 μL) of GD-iExo-001 was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.

Drug: GD-iExo-001

Normal saline control

PLACEBO COMPARATOR

Group1 (low-dose group), 2 papatients are treated with normal saline. Group2 (high-dose group), 2 papatients are treated with normal saline. One drop (about 50 μL) of normal saline was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.

Other: normal saline

Interventions

GD-iExo-001 DRUG

One drop (about 50 μL) of GD-iExo-001 was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.

GD-iExo-001 treatment

normal saline OTHER

One drop (about 50 μL) of normal saline was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.

Normal saline control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years, body mass index (BMI) between 18 and 35 kg/m2 (including boundary values);
• Overall good health except AD;
• Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria;
• Investigator overall assessment (IGA) score of 2 to 3;
• Participants with a history of subacute or chronic AD symptoms for at least 6 months;
• Participants with body surface area (BSA) of AD involvement of ≤5% at screening and baseline;
• Participants and their partners agreed to use effective contraception throughout the study period (from screening to 3 months after completion of treatment);
• Participants understood and voluntarily signed the informed consent form.

You may not qualify if:

• There are obvious active systemic or local infections, including but not limited to the infection of AD secondary infection, local bacterial infection in target lesion, local viral infection in target lesion, and local fungal infection in target lesion. Note: After the infection resolves, the patients can be re-screened;
• Presence of any of the following conditions: HB surface antigen (HBsAg) positive and / or HB e antigen (HBeAg) positive, HB e antibody (HBeAb) and / or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) copy number\> 2000 IU / mL; limited hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; positive human immunodeficiency virus (HIV) antibody; positive for syphilis (TPA) test;
• Inoculate live or attenuated vaccine within 4 weeks before screening or during the study period;
• Received allergen specific immunotherapy within 6 months before screening;
• Use of topical drugs known or may affect AD within 2 weeks before screening (including but not limited to topical glucocorticoids; calcineurin inhibitors: such as tacrolimus, pirolimus, etc.);
• Use of immunosuppressants and Janus kinase inhibitors within 4 weeks before screening;
• Use of any biological agent (such as IL-4 receptor inhibitors, IL-13 inhibitors) for 12 weeks before screening or 5 half-lives (whichever is longer);
• Received systemic or local Chinese medicine treatment (including Chinese medicine immersion treatment) within 2 weeks before screening;
• Treated with UV and photochemistry within 4 weeks prior to screening;
• Required systemic treatment of antiviral, antiparasitic, antigenic, or antifungals within 4 weeks prior to screening;
• With significant abnormal findings or laboratory values and clinical significance, such as white blood cell count \<3.0e9 / L; neutrophils \<1 LLN; hemoglobin \<90g / L; platelet \<100e9 / L; serum creatinine\> 1.5 ULN, ALT or AST 2 ULN; QTcF\> 450 msec (male) or QTcF\> 470 msec (female);
• Other combined (or co-occurrence) skin diseases that may affect the study evaluation, such as acne, psoriasis, lupus erythematosus, etc.; or large tattoos, birthmarks, skin scars, skin ulcers and other conditions that may affect the judgment of the investigator;
• Except for AD, any history of clinical major disease or clinically significant circulatory system abnormality, endocrine system abnormality, neurological or hematological disorders, immune system disease, psychiatric illness and metabolic instability; clinical significance is defined as the risk of the safety of the subject or aggravating the disease / disease during the study;
• Patients with a history of severe skin allergy and / or allergy to any ingredients of the product;
• History of cancer in the past 5 years (except for surgically removed squamous cell carcinoma, basal cell carcinoma, or skin carcinoma in situ);

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Guidon Pharmaceutics Ltd.: collaborator

Study Sites (1)

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Saline Solution

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hongzhong Jin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ju Qiao, PhD

CONTACT

+8615201125788; qiaoqiaoju@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: April 12, 2023
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)