Healthy Subjects
Conditions
Brief summary
The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects.
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.
Interventions
DRUGSHR7280
treatment
DRUGPlacebo oral tablet
blank control
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse events | Pre-dose to 28±2 days after dose administration | Part 1 and Part 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Endocrine Parameters: Testosterone | At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) | Part 1 |
| Endocrine Parameters: Estuarial | At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) | Part 2 |
| Endocrine Parameters:Progesterone | At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) | Part 2 |
| Endocrine Parameters: Luteinizing hormone | At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) | Part 2 |
| Endocrine Parameters: Follicle stimulating hormone | At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) | Part 2 |
| 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 |
Countries
China
Outcome results
None listed