Healthy Clinical Trial
Official title:
A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.
Verified date | January 2024 |
Source | Shanghai Huaota Biopharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 8, 2023 |
Est. primary completion date | June 9, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 exclusions criteria apply. |
Country | Name | City | State |
---|---|---|---|
New Zealand | New zealand Clinical Research | Auckland |
Lead Sponsor | Collaborator |
---|---|
Shanghai Huaota Biopharmaceutical Co., Ltd. |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects with drug related adverse events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug | up to 2000 hours | |
Secondary | Cmax | The maximum measured concentration of the analysis in plasma | up to 2000 hours | |
Secondary | AUC0-infinity | The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity | up to 2000 hours |
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