SKB575 (HBM7575) injection in healthy adults and adults with atopic dermatitis

A Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants

This trial will test whether SKB575 (HBM7575) injection is safe and how it behaves in healthy adults and in adults with moderate to severe atopic dermatitis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT07488065 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 study with two parts: a Phase Ia single ascending dose portion in healthy volunteers and a Phase Ib proof-of-concept portion in adults with moderate to severe atopic dermatitis. The study will monitor safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity after SKB575 or placebo injections. Participants will be randomly assigned and neither participants nor investigators will know treatment assignment. The trial is sponsored by Sichuan Kelun-Biotech and conducted at Huashan Hospital affiliated with Fudan University in Shanghai.

Who should consider this trial

Good fit: Ideal candidates are adults who meet the trial's age and weight limits and either are healthy volunteers (18–55 years) for the single ascending dose part or adults 18–70 years with moderate to severe atopic dermatitis for the proof-of-concept part.

Not a fit: People with mild atopic dermatitis, children, pregnant or breastfeeding individuals, or those who do not meet the study's age, weight, or health criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SKB575 could provide a new treatment option that safely reduces inflammation and symptoms for people with moderate to severe atopic dermatitis.

How similar studies have performed: Biologics with similar anti-inflammatory approaches have shown benefit in atopic dermatitis, but SKB575 itself is at an early, first-in-human/proof-of-concept stage with limited prior clinical data.

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.

Where this trial is running

Shanghai and 1 other locations

• Huashan Hospital Affiliated to Fudan University — Shanghai, China (Recruiting)
• Huashan Hospital Affiliated to Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xin Li, PhD

Conditions Atopic Dermatitis