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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf
Timepoint [2] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax
Timepoint [3] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax
Timepoint [4] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F
Timepoint [5] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F
Timepoint [6] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2
Timepoint [7] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [8] 0 0
Pharmacodynamics-Eosinophils
Timepoint [8] 0 0
Start of Treatment to end of study (approximately 34 weeks)
Secondary outcome [9] 0 0
Anti-drug-antibody
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
Terminated
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.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.
The objective of this study is to evaluate the safety, tolerability, pharmacokinetics
pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy
subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04855591
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr Richard Friend
Address 0 0
Nucleus Network
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/ct2/show/NCT04855591