Evaluating HB0034 in healthy Chinese adults
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects
Run by Shanghai Huaota Biopharmaceutical Co., Ltd. · NCT06716151 · Data updated 2026-11-12
This study tests if the new drug HB0034 is safe for healthy Chinese adults by giving them different doses and comparing it to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Shanghai Huaota Biopharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | December 6, 2024 |
| Main results expected | November 20, 2025 |
| Study ends | November 20, 2025 |
| Registry record updated | January 20, 2025 |
| Trial ID | NCT06716151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy males and females aged 18 to 55 with a BMI between 17.5 and 32 kg/m².
✕Probably not a fit
Patients with a history of significant health issues or those who are pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and tolerability of HB0034 in healthy Chinese adults through both single and multiple dose escalation. Participants will receive either HB0034 or a matching placebo, and the study will assess pharmacokinetics and immunogenicity. The aim is to ensure that the drug is safe for use in healthy individuals before further development.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new treatment that is safe for healthy individuals.
How similar studies have gone: While this study focuses on a specific drug, similar studies evaluating safety and tolerability in healthy subjects have shown success in the past.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Central Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Yuan Tang
- Email: yuan.tang@huaota.com
- Phone: +86 15821321563
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.