Status:
RECRUITING
A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
Lead Sponsor:
Shanghai Huaota Biopharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.
Detailed Description
This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.
Eligibility Criteria
Inclusion
- Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- 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
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
- 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.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06612970
Start Date
November 18 2024
End Date
October 1 2025
Last Update
September 8 2025
Active Locations (1)
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1
New Zealand Clinical Research
Christchurch, New Zealand, 8011