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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06612970




Registration number
NCT06612970
Ethics application status
Date submitted
23/09/2024
Date registered
25/09/2024

Titles & IDs
Public title
A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
Scientific title
A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.
Secondary ID [1] 0 0
HB0056-HV-01-01
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 - HB0056
Treatment: Drugs - Placebo

Active comparator: HB0056 dose group 1 - HB0056 single dose

Active comparator: HB0056 dose group 2 - HB0056 single dose

Active comparator: HB0056 dose group 3 - HB0056 single dose

Active comparator: HB0056 dose group 4 - HB0056 single dose

Active comparator: HB0056 dose group 5 - HB0056 single dose

Active comparator: HB0056 dose group 6 - HB0056 single dose

Active comparator: HB0056 dose group 7 - HB0056 single dose

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


Treatment: Drugs: HB0056
HB0056 Injection

Treatment: Drugs: Placebo
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 2700 hours
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Up to 2700 hours
Secondary outcome [2] 0 0
AUC0-infinity
Timepoint [2] 0 0
Up to 2700 hours

Eligibility
Key inclusion criteria
* 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.
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 applied.

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

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cory Sellwood
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jingjing Wang
Address 0 0
Country 0 0
Phone 0 0
086 15002154126
Fax 0 0
Email 0 0
jingjing.wang@huaota.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06612970