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Healthy SubjectsPhase 1NCT04554043

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

A Phase 1 study testing SHR7280 in people with Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
SHR7280
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteChina
Study dates
11 Sep 2020to 28 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • PART 1:
  • Healthy males , aged 18-65;
  • BMI 18 ~ 30 kg/m2;
  • Subjects in general good health. No clinically significant findings in Physical examination and auxiliary examination.
  • PART 2:
  • premenopausal females, aged 18-45;
  • BMI 18 ~ 30 kg/m2;
  • Subjects in general good health. No clinically significant findings in Physical examination and auxiliary examination.

Who cannot join

  • PART 1
  • Testosterone (T) < 12 nmol/L;
  • ALT or AST or total bilirubin exceeds the upper limit of normal;
  • Those with positive nicotine test and alcohol breath test before administration, and those with positive drug screening before administration;
  • Use of any medication within 1 month before administration; or use of medication that does not exceed 5 half-lives, whichever is longer;
  • Subjects with chronic diseases or serious diseases that affect drug absorption, distribution, metabolism and excretion;
Show all 25Show fewer
  • 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;
  • 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;
  • Subjects with severe infection, severe trauma or major surgery within 6 months before screening;
  • Positive results of infectious disease screening .
  • 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:
  • Pregnant or breast feeding;
  • FSH≥25U/L;
  • Positive serum pregnancy test (serum β-HCG test) result;
  • Abnormal uterine bleeding within 3 months prior to screening
  • ALT or AST or total bilirubin exceeds the upper limit of normal;
  • Those with positive nicotine test and alcohol breath test before administration, and those with positive drug screening before administration;
  • Use of any medication within 1 month before administration; or use of medication that does not exceed 5 half-lives, whichever is longer;
  • Subjects with chronic diseases or serious diseases that affect drug absorption, distribution, metabolism and excretion;
  • 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;
  • GnRH agonist use 6 months prior to Screening and GnRH antagonist or any sex hormone use 2 months prior to Screening.
  • Subjects with severe infection, severe trauma or major surgery within 6 months before screening
  • Positive results of infectious disease screening .
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

Other trials in China

About this study

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.

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.

Being tested
SHR7280, Placebo oral tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR7280Drug

    treatment

  • Placebo oral tabletDrug

    blank control

Study groups in NCT04554043
Study groupRoleWhat they receive
SHR7280 dose 1(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 2(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 3(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 4(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 5(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 1(female)Experimentaloral administration for 21 days,Phase I(PART 2)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 2(female)Experimentaloral administration for 21 days,Phase I(PART 2)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 3(female)Experimentaloral administration for 21 days,Phase I(PART 2)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 4(female)Experimentaloral administration for 21 days,Phase I(PART 2)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 6(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 7(male)Experimentaloral administration for 14 days,Phase I(PART 1)
Receives: Drug: SHR7280; Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse events

    Part 1 and Part 2

    Measured: Pre-dose to 28±2 days after dose administration

Secondary outcomes (16)

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

    Part 1 and Part 2

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

  12. Endocrine Parameters: Testosterone

    Part 1

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

  13. Endocrine Parameters: Estuarial

    Part 2

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

  14. Endocrine Parameters:Progesterone

    Part 2

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

  15. Endocrine Parameters: Luteinizing hormone

    Part 2

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start11 Sep 2020
  3. Primary completion28 Sep 2021
  4. Study completion28 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04554043
Sponsor's protocol ID
SHR7280-103
Status last verified
Oct 2021
First submitted
31 Aug 2020
Last updated
28 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Publications

  • Li X, Sun F, Zhang X, Lin P, Shen K, Shen Y, Ma L, Cao Y, Wang C. Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone receptor antagonist, in healthy men: a randomized, double-blind, placebo-controlled phase 1 study. BMC Med. 2023 Apr 3;21(1):129. doi: 10.1186/s12916-023-02834-6.

    PubMed 37013610

  • Xu Y, Hu W, Li J, Jiang X, Shi P, Shen K, Shen Y, Ma L, Cao Y. Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone antagonist in healthy premenopausal women. Front Pharmacol. 2022 Nov 23;13:1027648. doi: 10.3389/fphar.2022.1027648. eCollection 2022.

    PubMed 36506562

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR7280 in people with Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse events (time frame: Pre-dose to 28±2 days after dose administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04554043, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.

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