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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05460455
Registration number
NCT05460455
Ethics application status
Date submitted
13/07/2022
Date registered
15/07/2022
Date last updated
23/01/2024
Titles & IDs
Public title
A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants
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Scientific title
A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.
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Secondary ID [1]
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HB0034-03
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
Active Comparator: HB0034 dose group 1 - 8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
Active Comparator: HB0034 dose group 2 - 8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
Active Comparator: HB0034 dose group 3 - 8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
Treatment: Drugs: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
HB0034 and Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of subjects with drug related adverse events (AEs)
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Assessment method [1]
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An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
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Timepoint [1]
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up to 2000 hours
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Secondary outcome [1]
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Cmax
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Assessment method [1]
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The maximum measured concentration of the analysis in plasma
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Timepoint [1]
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up to 2000 hours
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Secondary outcome [2]
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AUC0-infinity
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Assessment method [2]
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The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
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Timepoint [2]
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up to 2000 hours
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/12/2023
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shanghai Huaota Biopharmaceutical Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy
subjects following multiple-dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05460455
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christian Schwabe
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Address
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NZCR OpCo limited AKL
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05460455
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