A Clinical Study to Evaluate the Effect of Food on the Ph... | NCT07035665

Studies
A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects

NCT07035665

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Status

Completed

Last Update Posted

Aug 20, 2025Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

IgA Nephropathy
Paroxysmal Nocturnal Hemoglobinuria

Interventions

HRS-5965 Capsules

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

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2025Actual

Primary Completion Date

Jul 22, 2025Actual

Completion Date

Jul 22, 2025Actual

First Submitted Date

Jun 16, 2025

First Submission Date that Met QC Criteria

Jun 16, 2025

First Posted Date

Jun 25, 2025Actual

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

Aug 19, 2025

Last Update Posted Date

Aug 20, 2025Actual

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

Description Module

Brief Summary

The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.

Detailed Description

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HRS-5965 Group A	Experimental		Drug: HRS-5965 Capsules
HRS-5965 Group B	Experimental		Drug: HRS-5965 Capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HRS-5965 Capsules	Drug	Oral doses of HRS-5965 capsules at fasted and fed conditions.	HRS-5965 Group A HRS-5965 Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak concentration (Cmax) of HRS-5965		Day 1 to Day 13.
Area under the plasma concentration - time curve from time 0 to the last quantifiable timepoint (AUC0-t)		Day 1 to Day 13.

Secondary Outcomes

Measure	Description	Time Frame
Time to peak concentration (Tmax)		Day 1 to Day 13.
Adverse events (AEs)		Day 1 to Day 20.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed the informed consent form pre-trial.
Aged 18-45 years at signing the informed consent form.
Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.

Exclusion Criteria:

Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever > 38°C.
Major trauma/surgery (≤8 weeks) or planned surgery during the study.
Drug abuse history or positive urine drug screen.
Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ZhongShan Hospital FuDan University		Shanghai	Shanghai Municipality	200032	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
D005922	Glomerulonephritis, IGA
D006457	Hemoglobinuria, Paroxysmal

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided