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Completed
NCT06612970
A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
Conditions: Healthy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 46
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Location: New Zealand Clinical Research Christchurch
Summary
The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT06612970). StuddyBuddy aggregates publicly available trial information.