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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
HB0056
DrugHB0056 Injection
Placebo
DrugPlacebo
Treatment groups
46 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: HB0056 dose group 1Active comparator 1 intervention
Group B: HB0056 dose group 2Active comparator 1 intervention
Group C: HB0056 dose group 3Active comparator 1 intervention
Group D: HB0056 dose group 4Active comparator 1 intervention
Group E: HB0056 dose group 5Active comparator 1 intervention
Group F: HB0056 dose group 6Active comparator 1 intervention
Group G: HB0056 dose group 7Active comparator 1 intervention
Group H: Matching placebo for each dose groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 2700 hoursSecondary outcomes
1
Cmax
The maximum measured concentration of the analysis in plasma.
Time frame
Up to 2700 hours2
AUC0-infinity
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Time frame
Up to 2700 hoursSponsors and contacts
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Source ClinicalTrials.gov