A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

Launched by SHANGHAI HUAOTA BIOPHARMACEUTICAL CO., LTD. · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HB0056 to see how safe it is for healthy adults when given as a single dose. The researchers want to ensure that the medication can be tolerated well by participants. They are currently looking for volunteers aged between 18 and 55 years who are in good health, meaning they don’t have serious medical conditions and meet specific health criteria, such as having a normal heart rate and blood pressure.

If you decide to participate, you can expect to undergo some health checks to confirm you meet the eligibility requirements. Participants will need to provide written consent, which means you agree to take part in the study after being informed about what it involves. It’s important to know that individuals with certain health issues, a history of cancer, or those who are pregnant or breastfeeding cannot join the trial. This study aims to help researchers better understand how HB0056 works in the body and its safety profile.

Gender

ALL

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.

Trial Officials