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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04855591




Registration number
NCT04855591
Ethics application status
Date submitted
20/04/2021
Date registered
22/04/2021
Date last updated
1/12/2021

Titles & IDs
Public title
A Trial of SHR-1703 in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects
Secondary ID [1] 0 0
SHR-1703-104-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-1703
Treatment: Drugs - Placebo

Experimental: SHR-1703 Dose Level 1 - Dose level 1 SHR-1703

Experimental: SHR-1703 Dose Level 2 - Dose level 2 SHR-1703

Experimental: SHR-1703 Dose Level 3 - Dose level 3 SHR-1703

Experimental: SHR-1703 Dose Level 4 (optional) - Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review


Treatment: Drugs: SHR-1703
SHR-1703 will be administered subcutaneously

Treatment: Drugs: Placebo
Placebo of SHR-1703 will be administered subcutaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Assessment method [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last
Assessment method [1] 0 0
Area under the concentration-time curve from time 0 to last time point after SHR-1703 administration
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf
Assessment method [2] 0 0
Area under the concentration-time curve from time 0 to infinity after SHR-1703 administration
Timepoint [2] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax
Assessment method [3] 0 0
Time to Cmax of SHR-1703
Timepoint [3] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax
Assessment method [4] 0 0
Maximum observed concentration of SHR-1703
Timepoint [4] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F
Assessment method [5] 0 0
Apparent clearance of SHR-1703
Timepoint [5] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F
Assessment method [6] 0 0
Apparent volume of distribution during terminal phase of SHR-1703
Timepoint [6] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2
Assessment method [7] 0 0
Terminal elimination half-life of SHR-1703
Timepoint [7] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [8] 0 0
Pharmacodynamics-Eosinophils
Assessment method [8] 0 0
Absolute eosinophils account and change from baseline in percentage
Timepoint [8] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [9] 0 0
Anti-drug-antibody
Assessment method [9] 0 0
The percentage of subjects with positive ADA titers over time for SHR-1703
Timepoint [9] 0 0
Start of Treatment to week 22 after IP administration

Eligibility
Key inclusion criteria
1. Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
2. Body weight =45 kg (Both male and female), body mass index (BMI) between =19.0 and =29.9 kg/m2, inclusive;
3. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
4. 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 30-days after last scheduled follow-up visit.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known history or suspected of being allergic to the study drug.
2. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
3. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
4. Use of any medicine within 4-weeks prior to the IP administration
5. Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
6. Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
7. Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
8. Patients with known or suspected parasitic infection within 6 months before screening
9. Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)
10. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
11. History of alcohol abuse within 3 months prior to the IP administration

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2021
Sample size
Target
Accrual to date
Final
1
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.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Dr Richard Friend
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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/NCT04855591