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Trial details imported from ClinicalTrials.gov
Ethics application status
A Study of SHR-1314 in Healthy Subjects
A Phase I, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Investigate Safety and Pharmacokinetics of SHR-1314 in Healthy Subjects
Universal Trial Number (UTN)
Other skin conditions
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 
Comparator / control treatment
Primary outcome 
Incidence and severity of adverse events
Secondary outcome 
Serum concentrations of SHR01314
Secondary outcome 
Serum anti-drug antibodies
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
5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures as specified in the protocol.
Both males and females
Can healthy volunteers participate?
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
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.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
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
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Atridia Pty Limited - Sydney
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
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 related presentations / publications
Nicholas Farinola, B.Sc,BMBS
Royal Adelaide Hospital