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

NCT07488065 | Recruiting Phase 1

• 1 other identifier: SKB575-I-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Pharmacokinetic (PK) assessment: Cmax

  From baseline to Day 225

• Pharmacokinetic (PK) assessment: Tmax

  From baseline to Day 225

• Pharmacokinetic (PK) assessment: AUClast

  From baseline to Day 225

• Presence of Anti-SKB575 Antibodies (ADA)

  From baseline to Day 225

• Pharmacodynamic (PD) Characteristics: Eosinophil

  From baseline to Day 225

Study Arms (8)

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

Interventions

SKB575 Injection/SKB575 Placebo DRUG

Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

A1; A2; A3; A4; A5; B1; B2; B3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Xin Li, PhD

CONTACT

86-028-67255165; lixin@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 23, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)