A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
NCT07488065 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-05-08
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
Interventions
- DRUG
-
SKB575 Injection/SKB575 Placebo
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Sponsors & Collaborators
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
Countries
- China
Study Locations
More Related Trials
-
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
NCT06468956 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
NCT06477835 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis
NCT07175233 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT06058156 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
NCT03568162 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT04875169 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase I Clinical Study to Evaluate SM17 in Chinese Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
NCT07103369 ·Status: COMPLETED ·Phase: PHASE1
-
Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
NCT04805411 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of SHR-1819 Injection in Adolescents With Severe Atopic Dermatitis
NCT07309055 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of AK120 (IL-4Rα) in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis
NCT04256174 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis
NCT05549947 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
NCT03747575 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis
NCT00703573 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
NCT03431610 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis
NCT04211415 ·Status: TERMINATED ·Phase: PHASE1
-
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis
NCT07465120 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
NCT07411755 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
NCT06397911 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis
NCT05525715 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
NCT06012812 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis
NCT04643457 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis
NCT07103174 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
NCT04684485 ·Status: COMPLETED ·Phase: PHASE2
-
Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis
NCT06277765 ·Status: COMPLETED ·Phase: PHASE3
-
Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
NCT05715320 ·Status: COMPLETED ·Phase: PHASE2