A Study to Evaluate HB0034 in Healthy Adult Participants
- Registration Number
- NCT05064345
- Lead Sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Brief Summary
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.
- Detailed Description
This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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 (HCG).
- Further exclusions criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HB0034 dose group 4 HB0034 HB0034 single dose Matching placebo for each dose group Placebo placebo, single dose HB0034 dose group 3 HB0034 HB0034 single dose HB0034 dose group 2 HB0034 HB0034 single dose HB0034 dose group 5 HB0034 HB0034 single dose HB0034 dose group 7 HB0034 HB0034 single dose HB0034 dose group 1 HB0034 HB0034 single dose HB0034 dose group 6 HB0034 HB0034 single dose
- Primary Outcome Measures
Name Time Method Percentage of subjects with drug related adverse events (AEs) up to 2000 hours An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
- Secondary Outcome Measures
Name Time Method Cmax up to 2000 hours The maximum measured concentration of the analysis in plasma
Trial Locations
- Locations (1)
New zealand Clinical Research
🇳🇿Auckland, New Zealand