NCT07035665

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

22 days

First QC Date

June 16, 2025

Last Update Submit

August 19, 2025

Conditions

IgA NephropathyParoxysmal Nocturnal Hemoglobinuria

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Time to peak concentration (Tmax)

    Day 1 to Day 13.

  • Adverse events (AEs)

    Day 1 to Day 20.

Study Arms (2)

HRS-5965 Group A

EXPERIMENTAL
Drug: HRS-5965 Capsules

HRS-5965 Group B

EXPERIMENTAL
Drug: HRS-5965 Capsules

Interventions

HRS-5965 CapsulesDRUG

Oral doses of HRS-5965 capsules at fasted and fed conditions.

HRS-5965 Group AHRS-5965 Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGAHemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2025

First Posted

June 25, 2025

Study Start

June 30, 2025

Primary Completion

July 22, 2025

Study Completion

July 22, 2025

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations

CN(1)