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CompletedNCT04554043Updated Oct 28, 2021

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

A Phase 1 interventional study of SHR7280 and Placebo oral tablet in Healthy Subjects, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects.

Read the 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.

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    SHR7280 dose 1(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 2(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 3(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 4(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 5(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 1(female)

    oral administration for 21 days,Phase I(PART 2)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 2(female)

    oral administration for 21 days,Phase I(PART 2)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 3(female)

    oral administration for 21 days,Phase I(PART 2)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 4(female)

    oral administration for 21 days,Phase I(PART 2)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 6(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

  • Experimental
    SHR7280 dose 7(male)

    oral administration for 14 days,Phase I(PART 1)

    Drug: SHR7280 · Drug: Placebo oral tablet

Interventions

  • DrugSHR7280

    treatment

  • DrugPlacebo oral tablet

    blank control

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse events

    Part 1 and Part 2

    Time frame: Pre-dose to 28±2 days after dose administration

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUCτ) after the first dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit( 28±2 days after dose administration)

  2. Maximum observed serum concentration (Cmax) after the first dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  3. Time to maximum observed serum concentration (Tmax) after the first dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  4. Time to elimination half-life (T1/2) ;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  5. Apparent total clearance(CL/F) of the drug from plasma after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  6. Apparent volume of distribution(Vz/F) after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  7. Maximum observed serum concentration (Cmax) after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  8. Time to maximum observed serum concentration (Tmax) after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  9. Trough observed serum concentration (Ctrough) after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  10. Accumulation Factor（Racc）after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  11. Area under the plasma concentration versus time curve (AUCτ) after last morning dose of SHR7280;

    Part 1 and Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  12. Endocrine Parameters: Testosterone

    Part 1

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  13. Endocrine Parameters: Estuarial

    Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  14. Endocrine Parameters:Progesterone

    Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  15. Endocrine Parameters: Luteinizing hormone

    Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

  16. Endocrine Parameters: Follicle stimulating hormone

    Part 2

    Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

07

Study locations

1 site
  • Affiliated Hospital of Qingdao University
    Qingdao, Shan Dong 266000, China
08

References and documents

Individual participant data

Plan to share: No — 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).

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04554043
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 18, 2020
Start date
Sep 11, 2020
Primary completion
Sep 28, 2021
Completion
Sep 28, 2021
Last update
Oct 28, 2021

Study contacts

Yu Cao, PhD
principal investigator · Hospital of Qingdao University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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