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

NCT04554043 | Completed Phase 1

• 1 other identifier: SHR7280-103
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse events

  Part 1 and Part 2

  Pre-dose to 28±2 days after dose administration

Secondary Outcomes (16)

• 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)

• 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)

• 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)

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

  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;

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

Study Arms (11)

SHR7280 dose 1(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 2(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 3(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 4(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 5(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 1(female)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 2(female)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 3(female)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 4(female)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 6(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 7(male)

EXPERIMENTAL

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

Drug: SHR7280; Drug: Placebo oral tablet

Interventions

SHR7280 DRUG

treatment

SHR7280 dose 1(female); SHR7280 dose 1(male); SHR7280 dose 2(female); SHR7280 dose 2(male); SHR7280 dose 3(female); SHR7280 dose 3(male); SHR7280 dose 4(female); SHR7280 dose 4(male); SHR7280 dose 5(male); SHR7280 dose 6(male); SHR7280 dose 7(male)

Placebo oral tablet DRUG

blank control

SHR7280 dose 1(female); SHR7280 dose 1(male); SHR7280 dose 2(female); SHR7280 dose 2(male); SHR7280 dose 3(female); SHR7280 dose 3(male); SHR7280 dose 4(female); SHR7280 dose 4(male); SHR7280 dose 5(male); SHR7280 dose 6(male); SHR7280 dose 7(male)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Related Publications (2)

• 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.

  PMID: 37013610 DERIVED

• 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.

  PMID: 36506562 DERIVED

Study Officials

• Yu Cao, PhD

  Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 18, 2020
• Study Start: September 11, 2020
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)