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

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

Overview

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.

Interventions

• Drug SKB575 Injection/SKB575 Placebo
  Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Primary outcome measures

• Number of participants with adverse events (AEs) /TEAEs [Time frame: From Baseline to Day 225]
• Proportion of participants achieving EASI-75 at Week 16 [Time frame: From Baseline throughout the study, up to Week 16]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

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:

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Huashan Hospital Affiliated to Fudan University — Shanghai
• Huashan Hospital Affiliated to Fudan University — Shanghai

Identifiers

NCT: NCT07488065 · SKB575-I-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗