A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Huaota Biopharmaceutical Co., Ltd.
About this trial
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 exclusion criterias apply.
Trial design
Design model
Parallel
Treatments tested in this trial
HB0034
DrugRecombinant Humanized Anti-IL-36R Monoclonal antibody
HB0034 matching placebo
DrugHB0034 matching Palcebo
Treatment groups
60 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Active Comparator: HB0034 dose group 1Experimental treatment 1 intervention
Group B: Active Comparator: HB0034 dose group 2Experimental treatment 1 intervention
Group C: Active Comparator: HB0034 dose group 3Experimental treatment 1 intervention
Group D: Active Comparator: HB0034 dose group 4Experimental treatment 1 intervention
Group E: Active Comparator: HB0034 dose group 5Experimental treatment 1 intervention
Group F: Active Comparator: HB0034 dose group 6Experimental treatment 1 intervention
Group G: Active Comparator: HB0034 dose group 7Experimental treatment 1 intervention
Group H: Placebo 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 the investigational drug
Time frame
up to 113 daysSecondary outcomes
1
Cmax
The maximum measured concentration of the analysis in plasma
Time frame
Up to 113 days2
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 113 daysSponsors and contacts
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Source ClinicalTrials.gov