A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: SKB575 Injection/SKB575 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xin Li, PhD; Phone Number: 86-028-67255165; Email: lixin@kelun.com

Study Locations

• China
  • Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital Affiliated to Fudan University
    • Contact: Jinhua Xu, PhD; Phone Number: 86-021-52887783; Email: xjhhsyy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: A2	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: A3	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: B2	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: B3	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: B1	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: A4	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Experimental: A5	Drug: SKB575 Injection/SKB575 Placebo; Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) /TEAEs	Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)	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	From Baseline throughout the study, up to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) assessment: Cmax	Maximum plasma concentration	From baseline to Day 225
Pharmacokinetic (PK) assessment: Tmax	Time to reach Cmax	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	From baseline to Day 225
Presence of Anti-SKB575 Antibodies (ADA)	Positive rate of participant with SKB575 antibodies	From baseline to Day 225
Pharmacodynamic (PD) Characteristics: Eosinophil	Change from baseline in total serum target concentrations of eosinophil	From baseline to Day 225
Pharmacodynamic (PD) Characteristics: IgE	Change from baseline in total serum target concentrations of IgE	From baseline to Day 225
Pharmacodynamic (PD) Characteristics: TARC	Change from baseline in total serum target concentrations of TARC	From baseline to Day 225

Collaborators and Investigators

• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: SKB575-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No