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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo oral tablet; Drug: SHR7280

Study type: Interventional

Funder types: Industry

Identifiers

NCT04554043

SHR7280-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 11 patient groups

SHR7280 dose 1(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 2(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 3(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 4(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 5(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 1(female)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 2(female)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 3(female)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 4(female)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 6(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet

SHR7280 dose 7(male)

Experimental group

Description:

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

Treatment:

Drug: SHR7280

Drug: Placebo oral tablet