A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Huaota Biopharmaceutical Co., Ltd.
About this trial
The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 .
Trial design
Treatments tested in this trial
- HB0056
- Placebo
Treatment groups
46 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov