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

October 21, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shan Dong
      • Qingdao, Shan Dong, China, 266000
        • Affiliated Hospital of Qingdao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse events
Time Frame: Pre-dose to 28±2 days after dose administration
Part 1 and Part 2
Pre-dose to 28±2 days after dose administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At pre-defined intervals from initial dose through final study visit( 28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters: Testosterone
Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Part 1
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters: Estuarial
Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Part 2
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters:Progesterone
Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Part 2
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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
At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yu Cao, PhD, Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR7280-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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