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New treatment option for Atopic Dermatitis
Official title A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
ClinicalTrials.gov ID: NCT07488065
What this study is testing
- What it's testing
- 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 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Phase Ia healthy participants must meet all of the following to be enrolled:
- 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. Phase Ib participants with moderate to severe AD must meet all of the following to be enrolled:
You likely can't join if
- History of any clinically significant disease of the cardiovascular, hematological, hepatic, renal, digestive, neurological, respiratory, or...
- History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis.
- Presence of skin scars, induration, inflammation, edema, ulceration, infection, bleeding, or other conditions at the intended injection site that are...
- Clinical signs of active infection within 4 weeks prior to randomization, including but not limited to urogenital infection, pulmonary infection...
- History of tuberculosis or complications of tuberculosis, or positive/abnormal findings of clinical significance based on chest X-ray/chest CT...
- people positive for Hepatitis B (HBsAg, HBeAg, HBeAb, or HBcAb), positive for Hepatitis C antibody, positive for HIV antibody, or positive for...
See the full eligibility criteria
- Phase Ia healthy participants must meet all of the following to be enrolled:
- 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. Phase Ib participants with moderate to severe AD must meet all of the following to be enrolled:
- 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...
- EASI ≥ 16 at screening and baseline visits;
- IGA ≥ 3 (on a 0 4 IGA scale, where 3 = moderate, 4 = severe) at screening and baseline visits;
- Body surface area (BSA) of lesions ≥ 10% at screening and baseline visits.
- 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.
- 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...
- History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis.
- 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)...
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.