Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The PK/PD Study of SHR7280 Tablets in Healthy Subjects.

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: NCT04554043
Recruitment Status : Completed
First Posted : September 18, 2020
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: SHR7280 Drug: Placebo oral tablet Phase 1

Detailed Description:
GNRH antagonists can be used to treat sex hormone-dependent diseases, and SHR7280 is an oral GNRH antagonist. The purpose of this study is to observe the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of SHR7280 in healthy subjects.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of SHR7280 Tablets in Healthy Subjects.
Actual Study Start Date : September 11, 2020
Actual Primary Completion Date : September 28, 2021
Actual Study Completion Date : September 28, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SHR7280 dose 1(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 2(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 3(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 4(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 5(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 1(female)
oral administration for 21 days,Phase I(PART 2)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 2(female)
oral administration for 21 days,Phase I(PART 2)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 3(female)
oral administration for 21 days,Phase I(PART 2)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 4(female)
oral administration for 21 days,Phase I(PART 2)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 6(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control
Experimental: SHR7280 dose 7(male)
oral administration for 14 days,Phase I(PART 1)
 Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants with Adverse events [ Time Frame: Pre-dose to 28±2 days after dose administration ]
    Part 1 and Part 2


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUCτ) after the first dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit( 28±2 days after dose administration) ]
    Part 1 and Part 2

  2. Maximum observed serum concentration (Cmax) after the first dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  3. Time to maximum observed serum concentration (Tmax) after the first dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  4. Time to elimination half-life (T1/2) ; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  5. Apparent total clearance(CL/F) of the drug from plasma after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  6. Apparent volume of distribution(Vz/F) after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  7. Maximum observed serum concentration (Cmax) after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  8. Time to maximum observed serum concentration (Tmax) after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  9. Trough observed serum concentration (Ctrough) after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  10. Accumulation Factor（Racc）after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  11. Area under the plasma concentration versus time curve (AUCτ) after last morning dose of SHR7280; [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1 and Part 2

  12. Endocrine Parameters: Testosterone [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 1

  13. Endocrine Parameters: Estuarial [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 2

  14. Endocrine Parameters:Progesterone [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 2

  15. Endocrine Parameters: Luteinizing hormone [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 2

  16. Endocrine Parameters: Follicle stimulating hormone [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Part 2


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

PART 1:

  1. Healthy males , aged 18-65;
  2. BMI 18 ~ 30 kg/m2;
  3. Subjects in general good health. No clinically significant findings in Physical examination and auxiliary examination.

PART 2:

  1. premenopausal females, aged 18-45;
  2. BMI 18 ~ 30 kg/m2;
  3. Subjects in general good health. No clinically significant findings in Physical examination and auxiliary examination.

Exclusion Criteria:

PART 1

  1. Testosterone (T) < 12 nmol/L;
  2. ALT or AST or total bilirubin exceeds the upper limit of normal;
  3. Those with positive nicotine test and alcohol breath test before administration, and those with positive drug screening before administration;
  4. Use of any medication within 1 month before administration; or use of medication that does not exceed 5 half-lives, whichever is longer;
  5. Subjects with chronic diseases or serious diseases that affect drug absorption, distribution, metabolism and excretion;
  6. Blood donation or donation of blood components within 1 month before screening, or loss of blood equivalent to at least 200 mL, or transfusion within 2 months;
  7. Use of GnRH agonists and GnRH antagonists within 6 months before screening and use of any androgens and antiandrogens within 5 half-lives before screening;
  8. Subjects with severe infection, severe trauma or major surgery within 6 months before screening;
  9. Positive results of infectious disease screening .
  10. Allergic constitution or allergy to two or more kinds of food and drugs, including known history of allergy to the study drug or any component of the study drug.

PART 2:

  1. Pregnant or breast feeding;
  2. FSH≥25U/L;
  3. Positive serum pregnancy test (serum β-HCG test) result;
  4. Abnormal uterine bleeding within 3 months prior to screening
  5. ALT or AST or total bilirubin exceeds the upper limit of normal;
  6. Those with positive nicotine test and alcohol breath test before administration, and those with positive drug screening before administration;
  7. Use of any medication within 1 month before administration; or use of medication that does not exceed 5 half-lives, whichever is longer;
  8. Subjects with chronic diseases or serious diseases that affect drug absorption, distribution, metabolism and excretion;
  9. Blood donation or donation of blood components within 1 month before screening, or loss of blood equivalent to at least 200 mL, or transfusion within 2 months;
  10. GnRH agonist use 6 months prior to Screening and GnRH antagonist or any sex hormone use 2 months prior to Screening.
  11. Subjects with severe infection, severe trauma or major surgery within 6 months before screening
  12. Positive results of infectious disease screening .
  13. Allergic constitution or allergy to two or more kinds of food and drugs, including known history of allergy to the study drug or any component of the study drug.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04554043


Locations
Layout table for location information
China, Shan Dong
Affiliated Hospital of Qingdao University
Qingdao, Shan Dong, China, 266000
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Yu Cao, PhD Hospital of Qingdao University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04554043    
Other Study ID Numbers: SHR7280-103
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Hengrui shall own the exclusive rights to all results, data, findings, radiological & diagnostic images, discoveries, inventions & specifications, whether patentable or not, that are originated, conceived, derived, produced, discovered, invented or otherwise made by Center, PI and/or Study Team Physicians and/or Members in connection with the performance of the Study (i.e. Results).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No