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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04554043
Collaborator
(none)
118
Enrollment
1
Location
11
Arms
12.6
Actual Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Sep 11, 2020
Actual Primary Completion Date :
Sep 28, 2021
Actual Study Completion Date :
Sep 28, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Number of Participants with Adverse events [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; [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; [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; [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) ; [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; [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; [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; [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; [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; [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; [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; [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 [At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)]

    Part 1

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

    Part 2

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

    Part 2

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

    Part 2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Qingdao University Qingdao Shan Dong China 266000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Yu Cao, PhD, Hospital of Qingdao University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04554043
Other Study ID Numbers:
  • SHR7280-103
First Posted:
Sep 18, 2020
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 28, 2021