Evaluating the safety of HB0056 in healthy adults
A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.
This study is testing the safety of a new drug called HB0056 in healthy adults to see how it affects them compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Shanghai Huaota Biopharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Christchurch) |
| Trial ID | NCT06612970 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of a single dose of HB0056 in healthy adult participants. It is designed as a single-dose escalation study to assess not only safety but also pharmacokinetics and immunogenicity. Participants will receive either HB0056 or a placebo, allowing researchers to compare the effects of the drug against a control group. The study aims to gather data that could inform future research and development of HB0056.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male or female adults aged 18 to 55 with a BMI between 18 and 32 kg/m².
Not a fit: Patients with a history of significant health issues or those currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety profile of HB0056, paving the way for its use in future therapeutic applications.
How similar studies have performed: Other studies evaluating similar single-dose interventions have shown promising results, but the specific approach of HB0056 is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Christchurch
- New Zealand Clinical Research — Christchurch, New Zealand (Recruiting)
Study contacts
- Principal investigator: Cory Sellwood — New Zealand Clinical Research
- Study coordinator: Jingjing Wang
- Email: jingjing.wang@huaota.com
- Phone: 086 15002154126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.