Study to Evaluate the Safety, Tolerability, Pharmacokinet... | NCT05930704

Studies
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women

NCT05930704

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Status

Unknown status

Last Update Posted

Jul 17, 2023Actual

Enrollment

45Estimated

Phase

Phase 1

Conditions

Osteoporosis

Interventions

SHR-2017 injection
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2023Actual

Primary Completion Date

Apr 12, 2025Estimated

Completion Date

Apr 12, 2025Estimated

First Submitted Date

Jun 26, 2023

First Submission Date that Met QC Criteria

Jun 26, 2023

First Posted Date

Jul 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR-2017 injection	Experimental		Drug: SHR-2017 injection
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-2017 injection	Drug	Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.	SHR-2017 injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		From day 1 up to 9 months

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed concentration of SHR-2017 (Cmax)		Day 1 pre-dose up to Day 253
Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017		Day 1 pre-dose up to Day 253

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women ages ≥ 50 years.
Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).
Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria:

History of malignancy.
Menopause due to simple hysterectomy.
Subjects with poor blood pressure control.
Subjects with positive tests for infectious diseases.
Have a history of diseases related to bone metabolism.
Use of drugs that may affect bone metabolism before administration.
Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening.
Female who are pregnant or breastfeeding.
Unable to tolerate venipunctures or have a history of fainting needles and blood.
Other reasons that the investigator consider it inappropriate to participate in the trial.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuanyuan Huang	Contact	0518-82342973		yuanyuan.huang@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Shandong First Medical University	Recruiting	Jinan	Shangdong	250000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided