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क्लिनिकल ट्रायल NCT07488065 के लिए एटोपिक डर्मेटाइटिस वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants चरण I 90 रैंडमाइज़्ड डबल-ब्लाइंड प्लेसबो-नियंत्रित
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07488065 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन एटोपिक डर्मेटाइटिस से जुड़ा हुआ है और यह एक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 90 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 25 मार्च 2026 से शुरू होगा। Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 जून 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 23 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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.
आधिकारिक शीर्षक
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
स्वास्थ्य स्थितियां
एटोपिक डर्मेटाइटिसअन्य अध्ययन आईडी
- SKB575-I-01
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-03-25
अंतिम अद्यतन प्रकाशित
2026-03-23
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-06-30
नामांकन (अनुमानित)
90
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकA1 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकA2 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकA3 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकA4 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकA5 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकB1 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकB2 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्रयोगात्मकB3 | SKB575 Injection/SKB575 Placebo Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
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.
- 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.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.अध्ययन केंद्रीय संपर्क
संपर्क: Xin Li, PhD, 86-028-67255165, [email protected]
2 1 देशों में अध्ययन स्थान
Huashan Hospital Affiliated to Fudan University, Shanghai, 200040, China
Jing Zhang, PhD, संपर्क, 86-021-52887926, [email protected]
Huashan Hospital Affiliated to Fudan University, Shanghai, 200040, China