A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
NCT ID: NCT06612970
Last Updated: 2025-09-08
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
46 participants
INTERVENTIONAL
2024-11-18
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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HB0056 dose group 1
HB0056 single dose
HB0056
HB0056 Injection
HB0056 dose group 2
HB0056 single dose
HB0056
HB0056 Injection
HB0056 dose group 3
HB0056 single dose
HB0056
HB0056 Injection
HB0056 dose group 4
HB0056 single dose
HB0056
HB0056 Injection
HB0056 dose group 5
HB0056 single dose
HB0056
HB0056 Injection
HB0056 dose group 6
HB0056 single dose
HB0056
HB0056 Injection
HB0056 dose group 7
HB0056 single dose
HB0056
HB0056 Injection
Matching placebo for each dose group
placebo, single dose
Placebo
Placebo
Interventions
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HB0056
HB0056 Injection
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥ 18 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 .
* Further exclusions criteria applied.
18 Years
55 Years
ALL
Yes
Sponsors
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Shanghai Huaota Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Cory Sellwood
Role: PRINCIPAL_INVESTIGATOR
New Zealand Clinical Research
Locations
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New Zealand Clinical Research
Christchurch, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HB0056-HV-01-01
Identifier Type: -
Identifier Source: org_study_id
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