Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
HB0034-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects with drug related adverse events (AEs)
Timepoint [1] 0 0
up to 2000 hours
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
up to 2000 hours
Secondary outcome [2] 0 0
AUC0-infinity
Timepoint [2] 0 0
up to 2000 hours

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/12/2023
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Huaota Biopharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.
Trial website
https://clinicaltrials.gov/study/NCT05460455
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Schwabe
Address 0 0
NZCR OpCo limited AKL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05460455