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The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

Primary Purpose

Endometriosis

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR7280

Placebo oral tablet

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Phase I/II

premenopausal females, aged 18-45
History of regular menstrual cycles
Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.
Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray Phase I (only) Participant has mild or moderate pelvic pain associated with endometriosis at Screening.

Phase II(only) Participant has moderate or severe pelvic pain associated with endometriosis at Screening.

Exclusion Criteria:

Phase I/II

Subjects with severe trauma or surgery within 6 months prior to the screening；
Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
Pregnant or Serum β-human chorionic gonadotropin (hCG)> 5 Million International Units(mIU)/mL at screening or baseline
Pregnant or breast feeding ;
Have pelvic pain that is not caused by endometriosis
Abnormal uterine bleeding
Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist or danazol or have received any of these agents within 6 months of the start of screening.
Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening.

Phase I (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening; Phase II (only) Screening dual-energy x-ray absorptiometry (DXA) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (T-score at or below -1.5)

Sites / Locations

Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SHR7280 dose 1

SHR7280 dose 2

SHR7280 dose 3

SHR7280 dose 4

SHR7280 low dose

SHR7280 high dose

Placebo

Arm Description

oral administration for 21days,Phase I

oral administration for 84days,Phase II

oral administration for 84days, Phase II

Outcomes

Primary Outcome Measures

Number of Participants with Adverse events

Phase I

Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS at weeks 12

Phase II daily assessment of dysmenorrhea score on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

Secondary Outcome Measures

PK markers of SHR7280: area under the plasma concentration versus time curve (AUC)

Phase I & II

PK markers of SHR7280: time to maximum plasma concentration(Tmax)

Phase I & II

PK markers of SHR7280: maximum plasma concentration(Cmax)

Phase I & II

PK markers of SHR7280: half-time(t1/2)

Phase I & II

PK markers of SHR7280: apparent clearance(CL/F)

Phase I & II

PK markers of SHR7280: apparent volume of distribution(Vz/F)

Phase I & II

PD markers of SHR7280: Concentration of Estradiol(E2)

Phase I & II

PD markers of SHR7280: Concentration of Progesterone(P)

Phase I & II

PD markers of SHR7280: Concentration of Follicle stimulating hormone(FSH)

Phase I & II

PD markers of SHR7280: Concentration of Luteinizing hormone(LH)

Phase I & II

Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS

Phase II

Change From Baseline in the Monthly Mean score for pelvic pain as measured by VAS

Phase II

Change From Baseline in the Monthly Mean Dysmenorrhea Score

Phase II

Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score and Dyspareunia Score

Phase II

Change from baseline to monthly analgesic use to treat endometriosis-associated pain

Phase II

Patient Global Impression of Change (PGIC) score at week 12

Phase II

Adverse events

Full Information

NCT ID

NCT04417972

First Posted

May 21, 2020

Last Updated

December 19, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04417972

Brief Title

The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

Official Title

A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics ,Pharmacodynamics and Efficacy of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 30, 2020 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

Detailed Description

Endometriosis is a common disease, aﬀecting 5-10% of women of reproductive age . It is an estrogen-dependent and estrogen-driven disease and so hormonal manipulation and suppression of estrogen production form the basis of the majority of medical treatment. The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

207 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR7280 dose 1

Arm Type

Experimental

Arm Description

oral administration for 21days,Phase I

Arm Title

SHR7280 dose 2

Arm Type

Experimental

Arm Description

oral administration for 21days,Phase I

Arm Title

SHR7280 dose 3

Arm Type

Experimental

Arm Description

oral administration for 21days,Phase I

Arm Title

SHR7280 dose 4

Arm Type

Experimental

Arm Description

oral administration for 21days,Phase I

Arm Title

SHR7280 low dose

Arm Type

Active Comparator

Arm Description

oral administration for 84days,Phase II

Arm Title

SHR7280 high dose

Arm Type

Active Comparator

Arm Description

oral administration for 84days, Phase II

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

oral administration for 84days, Phase II

Intervention Type

Drug

Intervention Name(s)

SHR7280

Intervention Description

treatment

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

blank control

Primary Outcome Measure Information:

Title

Number of Participants with Adverse events

Description

Phase I

Time Frame

Pre-dose to 28±2 days after dose administration

Title

Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS at weeks 12

Description

Phase II daily assessment of dysmenorrhea score on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

Time Frame

Baseline and weeks 12

Secondary Outcome Measure Information:

Title

PK markers of SHR7280: area under the plasma concentration versus time curve (AUC)

Description

Phase I & II

Time Frame