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Safety, Tolerability and PK/PD of SHR1459 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668509
Recruitment Status : Unknown
Verified September 2018 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This was a phase I, single-center, double-blind, randomized, placebo-controlled study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of the investigational medicinal product in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: SHR1459 Phase 1

Detailed Description:
The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR1459, in Healthy Volunteers
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Experimental: Cohort 1
oral adminstration of SHR1459, dose 1
Drug: SHR1459
oral adminstration, single dose
Other Name: Placebo

Experimental: Cohort 2
oral adminstration of SHR1459, dose 2
Drug: SHR1459
oral adminstration, single dose
Other Name: Placebo

Experimental: Cohort 3
oral adminstration of SHR1459, dose 3
Drug: SHR1459
oral adminstration, single dose
Other Name: Placebo




Primary Outcome Measures :
  1. Safety and tolerability of single oral doses of SHR1459 determined by adverse events [ Time Frame: within 4 days after single dose ]
    Frequency and severity of AEs and serious AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, of any ethnic origin, age ≥18 and ≤45 years of age;
  • BMI ≥19 and ≤26 kg/m2; Men's weight≥ 50kg, Women's weight ≥ 45kg;
  • Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator; all clinical tests of blood, urine, ECG and X-ray are within the normal range or show no clinically relevant deviations as judged by the Investigator;
  • There is no birth plan during the trial and within 1 month after the completion of the trial, and the subject must agree to use one of the effective contraceptive methods;
  • Able to comprehend and abide by the study restrictions, and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria:

  • Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
  • Has a history of malignant or lymphoproliferative disorders;
  • Has a history of bleeding tendency or coagulopathy (eg, uncontrolled autoimmune hemolysis and thrombocytopenic purpura, severe hematopoietic defects, gastrointestinal bleeding), or recent bleeding events;
  • Has a history of stroke or intracranial hemorrhage within 6 months prior to screening;
  • Has any surgery performed within 3 months prior to screening, or during the study period and within 1 month after the end of the study;
  • Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
  • Has diseases affecting drug absorption, distribution, metabolism, and excretion (eg, gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc);
  • Has active tuberculosis by clinical symptoms, signs, laboratory tests, or X-ray examinations;
  • Has infections including acute and chronic infections, local infections such as sepsis, abscesses, and opportunistic infections that were clinically significant by the investigator in the 3 months prior to screening;
  • Has blood donation and donated ≥400 mL within 3 months before screening ; or received any blood product infusion; or received plasma exchange or blood cell clearance treatment;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668509


Contacts
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Contact: Hua Zhang, MD +86-512-67780040 sdfyy8040@126.com

Locations
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China
Xu qian, M.D. Ph.D Recruiting
Shanghai, China
Contact: Qian Xu, Ph.D    +86-18721043271    xuqian@hrglobe.cn   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03668509    
Other Study ID Numbers: SHR1459-101
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR1459
Phase 1