Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05064345




Registration number
NCT05064345
Ethics application status
Date submitted
22/09/2021
Date registered
1/10/2021
Date last updated
14/09/2022

Titles & IDs
Public title
A Study to Evaluate HB0034 in Healthy Adult Participants
Scientific title
A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects
Secondary ID [1] 0 0
HB0034-01
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 - HB0034
Treatment: Drugs - Placebo

Active comparator: HB0034 dose group 1 - HB0034 single dose

Active comparator: HB0034 dose group 2 - HB0034 single dose

Active comparator: HB0034 dose group 3 - HB0034 single dose

Active comparator: HB0034 dose group 4 - HB0034 single dose

Active comparator: HB0034 dose group 5 - HB0034 single dose

Active comparator: HB0034 dose group 6 - HB0034 single dose

Active comparator: HB0034 dose group 7 - HB0034 single dose

Placebo comparator: Matching placebo for each dose group - placebo, single dose


Treatment: Drugs: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody

Treatment: Drugs: Placebo
Palcebo
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

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 (HCG).
* Further exclusions criteria apply.

Study design
Purpose of the study
Treatment
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
3/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2022
Sample size
Target
Accrual to date
Final
56
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 a single dose.
Trial website
https://clinicaltrials.gov/study/NCT05064345
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/NCT05064345