A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants (NCT07488065) | Clinical Trial Compass
RecruitingPhase 1
A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
China90 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form.
✓. Age at the time of signing the informed consent form is 18-55 years (inclusive), any gender.
✓. Male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg; body mass index \[BMI\] is 18.0-28.0 kg/m² (inclusive).
✓. No clinically significant abnormalities.
✓. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form.
✓. Age at the time of signing the informed consent form is 18-70 years (inclusive), any gender.
✓. Participant weight must be ≥ 45.0 kg.
✓. 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:
Exclusion criteria
✕. 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.
✕. History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis.
What they're measuring
1
Number of participants with adverse events (AEs) /TEAEs
Timeframe: From Baseline to Day 225
2
Proportion of participants achieving EASI-75 at Week 16
Timeframe: From Baseline throughout the study, up to Week 16
. Presence of skin scars, induration, inflammation, edema, ulceration, infection, bleeding, or other conditions at the intended injection site that are unsuitable for subcutaneous injection.
✕. 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.
✕. 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™).
✕. Subjects positive for Hepatitis B (HBsAg, HBeAg, HBeAb, or HBcAb), positive for Hepatitis C antibody, positive for HIV antibody, or positive for syphilis serology.