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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02934412




Registration number
NCT02934412
Ethics application status
Date submitted
20/09/2016
Date registered
17/10/2016
Date last updated
14/11/2017

Titles & IDs
Public title
A Study of SHR-1314 in Healthy Subjects
Scientific title
A Phase I, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety and Pharmacokinetics of SHR-1314 in Healthy Subjects
Secondary ID [1] 0 0
SHR-1314-A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1314
Treatment: Drugs - placebo

Experimental: SHR-1314 20mg - 20mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Experimental: SHR-1314 40mg - 40mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Experimental: SHR-1314 80mg - 80mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Experimental: SHR-1314 160mg - 160mg SHR-1314 or placebo is administered subcutaneously to healthy subjects

Experimental: SHR-1314 240mg - 240mg SHR-1314 or placebo is administered subcutaneously to healthy subjects


Treatment: Drugs: SHR-1314
Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.

Treatment: Drugs: placebo
Single subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
70 days
Secondary outcome [1] 0 0
Serum concentrations of SHR01314
Timepoint [1] 0 0
70 days
Secondary outcome [2] 0 0
Serum anti-drug antibodies
Timepoint [2] 0 0
70 days

Eligibility
Key inclusion criteria
1. Provide written informed consent before any study assessment is performed.
2. Male or female between the ages of 18 and 55 years (inclusive) at screening,
3. Good general health as defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including measurement of vital signs, 12-lead ECG, and clinical laboratory tests. (Evaluations must be considered "not clinically significant (NCS)" if outside of the reference range).
4. Body Mass Index (BMI) of 18 to 30 kg/m2 (inclusive), and a total body weight =50 kg at screening.
5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
2. Use of other investigational drugs within 5 half-lives of screening, or within 30 days of screening (for small molecules), or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test at screening or Day -1.
4. Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until 2 months after drug administration (approximately 5 half-lives). Effective contraception is defined use of two of the following methods of contraception:

* Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps).
* Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Male sterilization
* Use of established oral, injected or implanted hormonal methods of contraception,
* Use of an intrauterine device or intrauterine system.
5. Blood donation of approximately 500 mL within 56 days prior to dosing on Day 1 and for the duration of the study.
6. A positive urine drug screen at screening and Day -1.
7. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 100 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening.
8. Use of tobacco or nicotine containing products (including e-cigarettes) at any time within six months before screening and for the duration of the study.
9. History of hypersensitivity to any of the study biologics, drugs or to drugs of similar chemical classes.
10. History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
11. History or complication of tuberculosis.
12. Has a clinically significant abnormality on the screening chest x-ray that, in the opinion of the investigator, could affect the subject's safety or ability to participate in the study; including, but not limited to, evidence of previous exposure to tuberculosis.
13. History of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result at screening.
14. Positive hepatitis B or hepatitis C test result at Screening
15. Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic pulmonary disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
16. Use of live vaccines (attenuated) within 3 months before study Day 1 or at any time during the study.
17. Evidence of latent tuberculosis by QuantiFERON screening.
18. Use of any of the following, unless agreed as non-clinically relevant by the Investigator and the Sponsor:

1. Prescription medication within four weeks prior to dosing on Day 1
2. Over-the-counter medication (excluding paracetamol) within seven days prior to the treatment day. Paracetamol use must be limited to 2 g per day and no more than three days usage in the four weeks prior to dosing on Day 1
3. Vitamin therapy or dietary supplements within seven days prior to dosing on Day 1 and for the duration of the study
4. Herbal supplements within 28 days prior to the dosing on Day 1 and for the duration of the study.

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 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
22/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
Accrual to date
Final
40
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 randomized, double-blind, placebo-controlled, single dose escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of approximately 40 subjects dosed at one study site.
Trial website
https://clinicaltrials.gov/study/NCT02934412
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas Farinola, B.Sc,BMBS
Address 0 0
Royal Adelaide Hospital
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/study/NCT02934412