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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06612970). StuddyBuddy aggregates publicly available trial information.