A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
- Registration Number
- NCT05460455
- 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 multiple-dose.
- Detailed Description
This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HB0034 dose group 3 Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo 8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo HB0034 dose group 1 Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo 8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo HB0034 dose group 2 Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo 8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
- 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 AUC0-infinity up to 2000 hours The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
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