A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
NCT ID: NCT06716151
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2024-12-06
2025-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Comparator: HB0034 dose group 1
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Active Comparator: HB0034 dose group 2
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Active Comparator: HB0034 dose group 3
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Active Comparator: HB0034 dose group 4
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Active Comparator: HB0034 dose group 5
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Active Comparator: HB0034 dose group 6
8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Active Comparator: HB0034 dose group 7
8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Placebo group
17 subjects receive placebo
HB0034 matching placebo
HB0034 matching Palcebo
Interventions
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HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
HB0034 matching placebo
HB0034 matching Palcebo
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Exclusion Criteria
Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
18 Years
45 Years
ALL
Yes
Sponsors
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Shanghai Huaota Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Central Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Qing Wen
Role: backup
Other Identifiers
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HB0034-HV-01-03
Identifier Type: -
Identifier Source: org_study_id
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