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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04561128




Registration number
NCT04561128
Ethics application status
Date submitted
29/08/2020
Date registered
23/09/2020
Date last updated
31/12/2020

Titles & IDs
Public title
A Trial of SHR-1819 in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects
Secondary ID [1] 0 0
SHR-1819-I-101-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1819
Treatment: Drugs - Placebo

Experimental: SHR-1819 - Experimental: SHR-1819

Placebo Comparator: Placebo - Placebo comparator: placebo


Treatment: Drugs: SHR-1819
SHR-1819 will be subcutaneously administered with different dose levels

Treatment: Drugs: Placebo
Placebo will be subcutaneously administered with different dose levels

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events - Incidence and severity of adverse events
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 13 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last - Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 13 weeks)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf - Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration
Timepoint [2] 0 0
Start of Treatment to end of study (approximately 13 weeks)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax - Time to Cmax of SHR-1819
Timepoint [3] 0 0
Up to 13 weeks
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax - Maximum observed concentration of SHR-1819
Timepoint [4] 0 0
Up to 13 weeks
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F - Apparent clearance of SHR-1819
Timepoint [5] 0 0
Up to 13 weeks
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F - Apparent volume of distribution during terminal phase of SHR-1819
Timepoint [6] 0 0
Up to 13 weeks
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2 - Terminal elimination half-life of SHR-1819
Timepoint [7] 0 0
Up to 13 weeks
Secondary outcome [8] 0 0
Change from baseline to end of treatment for TARC/CCL17 - TARC/CCL17
Timepoint [8] 0 0
Up to 13 weeks
Secondary outcome [9] 0 0
Change from baseline to end of treatment for IgE - IgE
Timepoint [9] 0 0
Up to 13 weeks
Secondary outcome [10] 0 0
Immunogenicy of SHR-1819 after administration - Anti-drug antibody
Timepoint [10] 0 0
Up to 13 weeks

Eligibility
Key inclusion criteria
- Ability to understand the trial procedures and possible adverse events, volunteers to
participate in the trial, and provides written informed consent.

- Be able to comply with all the requirements and able to complete the study.

- Male or female aged between 18 years and 55 years (inclusive) at the date of signed
consent form.

- No clinically significant abnormalities in medical history, general physical
examination, vital signs, and laboratory tests.

- Men and women of childbearing potential (WOCBP) must agree to take effective
contraceptive methods and have no plan to have a child from signing the consent form
to 16 weeks after IP administration.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency
virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;

- Participation in clinical trials of other investigational drugs or medical devices
within 3 months prior to screening (according to the date of signed consent form), or
in the follow-up period of a clinical study

- Severe injuries or surgeries within 6 months before screening or plan to do surgeries
during the trial

- Any other circumstances that, in the investigator's judgment, may increase the risk
associated with the subject's participation in and completion of the study or could
preclude the evaluation of the subject's response

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Atridia Pty Limited - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation
phase 1 study.
Trial website
https://clinicaltrials.gov/show/NCT04561128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You
Address 0 0
Country 0 0
Phone 0 0
+610192990433
Fax 0 0
Email 0 0
kathyyou@atridia.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04561128