Atopic DermatitisPhase 1NCT07488065
A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
A Phase 1 study of Atopic Dermatitis, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 31 Mar 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase Ia healthy participants must meet all of the following inclusion criteria 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 inclusion criteria to be enrolled:
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- 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:
- 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.
Who cannot join
- 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.
- 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.
- NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
Jing Zhang, PhD, 86-021-52887926, Zhangj_fudan@163.com
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
Jinhua Xu, PhD, 86-021-52887783, xjhhsyy@163.com
About this study
Official title: 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 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.
- Conditions
- Atopic Dermatitis
- Being tested
- SKB575 Injection/SKB575 Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB575 Injection/SKB575 PlaceboDrug
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| A2 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| A3 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| A4 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| A5 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| B1 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| B2 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
| B3 | Experimental | Not described Receives: Drug: SKB575 Injection/SKB575 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) /TEAEs
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Measured: From Baseline to Day 225
Proportion of participants achieving EASI-75 at Week 16
EASI 75 is defined by reduction of EASI score by ≥75% from baseline
Measured: From Baseline throughout the study, up to Week 16
Secondary outcomes (7)
Pharmacokinetic (PK) assessment: Cmax
Maximum plasma concentration
Measured: From baseline to Day 225
Pharmacokinetic (PK) assessment: Tmax
Time to reach Cmax
Measured: From baseline to Day 225
Pharmacokinetic (PK) assessment: AUClast
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration
Measured: From baseline to Day 225
Presence of Anti-SKB575 Antibodies (ADA)
Positive rate of participant with SKB575 antibodies
Measured: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: Eosinophil
Change from baseline in total serum target concentrations of eosinophil
Measured: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: IgE
Change from baseline in total serum target concentrations of IgE
Measured: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: TARC
Change from baseline in total serum target concentrations of TARC
Measured: From baseline to Day 225
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start31 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488065
- Sponsor's protocol ID
- SKB575-I-01
- Status last verified
- May 2026
- First submitted
- 11 Mar 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07488065
- Acronym / sponsor ID
- SKB575-I-01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| A2 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| A3 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| A4 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| A5 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| B1 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| B2 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
| B3 | Experimental | Drug: SKB575 Injection/SKB575 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Phase Ia healthy participants must meet all of the following inclusion criteria 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.
Key exclusion criteria (7 listed)
- 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.
- 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™).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB575 Injection/SKB575 PlaceboPharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection | Drug | A1, A2, A3, A4, A5, B1, B2, B3 |
Primary outcome
Number of participants with adverse events (AEs) /TEAEs
Time frame: From Baseline to Day 225
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Proportion of participants achieving EASI-75 at Week 16
Time frame: From Baseline throughout the study, up to Week 16
EASI 75 is defined by reduction of EASI score by ≥75% from baseline
7 secondary outcomes
Pharmacokinetic (PK) assessment: Cmax
Time frame: From baseline to Day 225
Pharmacokinetic (PK) assessment: Tmax
Time frame: From baseline to Day 225
Pharmacokinetic (PK) assessment: AUClast
Time frame: From baseline to Day 225
Presence of Anti-SKB575 Antibodies (ADA)
Time frame: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: Eosinophil
Time frame: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: IgE
Time frame: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: TARC
Time frame: From baseline to Day 225
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Atopic Dermatitis, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Li, PhD (86-028-67255165, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) /TEAEs (time frame: From Baseline to Day 225). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.