A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

Launched by SHANGHAI HUAOTA BIOPHARMACEUTICAL CO., LTD. · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called HB0034 to see how safe it is for healthy adults. The main goal is to determine if people can tolerate a single dose or multiple doses of the drug without any serious side effects. The trial is currently looking for participants aged 18 to 55 years who are in good health, meaning they do not have any significant medical conditions and meet certain health criteria.

If you or someone you know is interested in participating, you'll need to be healthy and have a body weight within a specific range. Participants will go through some health checks to ensure they meet the study's requirements. During the trial, you can expect to receive either one dose of the drug or multiple doses and will be monitored for any reactions to it. It's important to note that pregnant or breastfeeding women and those with certain health histories will not be eligible to join. This study aims to gather important information that could help with future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male or female subjects age ≥ 18 and ≤ 55 years.
• • Body Mass Index (BMI) ≥ 17.5 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 exclusion criterias apply.