NCT07488065 A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
| NCT ID | NCT07488065 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2026-03-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.
Eligibility Criteria
Inclusion Criteria: Phase Ia healthy participants must meet all of the following inclusion criteria to be enrolled: 1. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form. 2. Age at the time of signing the informed consent form is 18-55 years (inclusive), any gender. 3. Male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg; body mass index \[BMI\] is 18.0-28.0 kg/m² (inclusive). 4. No clinically significant abnormalities. Phase Ib participants with moderate to severe AD must meet all of the following inclusion criteria to be enrolled: 1. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form. 2. Age at the time of signing the informed consent form is 18-70 years (inclusive), any gender. 3. Participant weight must be ≥ 45.0 kg. 4. At screening, the diagnosis of AD meets the American Dermatology Consensus Criteria (2014) (see Appendix 4) and disease duration is ≥ 1 year; and at both screening and randomization, all of the following conditions are satisfied: 1. EASI ≥ 16 at screening and baseline visits; 2. IGA ≥ 3 (on a 0 4 IGA scale, where 3 = moderate, 4 = severe) at screening and baseline visits; 3. Body surface area (BSA) of lesions ≥ 10% at screening and baseline visits. 5. Prior to screening, the participant has received at least 4 weeks of potent or 2 weeks of super potent topical corticosteroids (or systemic corticosteroids), or topical calcineurin inhibitor. Exclusion Criteria: 1. History of any clinically significant disease of the cardiovascular, hematological, hepatic, renal, digestive, neurological, respiratory, or psychiatric systems, or metabolic disorders, or any other disease or physiological condition that may interfere with the trial results. 2. History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis. 3. Presence of skin scars, induration, inflammation, edema, ulceration, infection, bleeding, or other conditions at the intended injection site that are unsuitable for subcutaneous injection. 4. Clinical signs of active infection within 4 weeks prior to randomization, including but not limited to urogenital infection, pulmonary infection, acute sinusitis, appendicitis, bloodstream infection, etc. 5. History of tuberculosis or complications of tuberculosis, or positive/abnormal findings of clinical significance based on chest X-ray/chest CT, physical examination, and T-cell interferon-gamma release assay (TIGRA) (e.g., T-Spot or Quanti-FERON®-TB Gold™). 6. Subjects positive for Hepatitis B (HBsAg, HBeAg, HBeAb, or HBcAb), positive for Hepatitis C antibody, positive for HIV antibody, or positive for syphilis serology. NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07488065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07488065 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07488065 currently recruiting?
Yes, NCT07488065 is actively recruiting participants. Contact the research team at lixin@kelun.com for enrollment information.
Where is the NCT07488065 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07488065 clinical trial?
NCT07488065 is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. The trial plans to enroll 90 participants.
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