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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04800263




Registration number
NCT04800263
Ethics application status
Date submitted
11/03/2021
Date registered
16/03/2021

Titles & IDs
Public title
A Trial of SHR-1905 in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 in Healthy Subjects
Secondary ID [1] 0 0
SHR-1905-I-101-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1905
Treatment: Drugs - Placebo

Experimental: SHR-1905 Dose Level 1 - SHR-1905 Dose level 1

Experimental: SHR-1905 Dose Level 2 - SHR-1905 Dose level 2

Experimental: SHR-1905 Dose Level 3 - SHR-1905 Dose level 3

Experimental: SHR-1905 Dose Level 4 - SHR-1905 Dose level 4

Experimental: SHR-1905 Dose Level 5 - SHR-1905 Dose level 5


Treatment: Drugs: SHR-1905
SHR-1905 will be injected subcutaneously

Treatment: Drugs: Placebo
Placebo will be injected subcutaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf
Timepoint [2] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax
Timepoint [3] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax
Timepoint [4] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F
Timepoint [5] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F
Timepoint [6] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2
Timepoint [7] 0 0
Start of Treatment to end of study (approximately 16 weeks)
Secondary outcome [8] 0 0
Anti-Drug antibody
Timepoint [8] 0 0
Start of Treatment to end of study (approximately 16 weeks)

Eligibility
Key inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight =45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
4. For healthy subjects, no clinically significant abnormalities.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 6 months before screening.
3. Subjects with infecious disease.
4. Hyper/Hypotension at screening and at check in.
5. Clinically significant abnormalities in 12-Lead ECG
6. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
7. Positive urine drug screen .
8. Subject who cannot perform venous blood sampling.
9. Known history or suspected of being allergic to the study drugs and their excipients.
10. Use of any medicine within 4-weeks or within 5 half-lives
11. History of alcohol abuse within 3 months prior to the IP administration .
12. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
13. in the investigator's judgment, may increase the risk to the subject

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
27/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2022
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty 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
Address 0 0
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

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/NCT04800263