IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria
Conditions
Brief summary
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
Interventions
Oral doses of HRS-5965 capsules at fasted and fed conditions.
Sponsors
Chengdu Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed the informed consent form pre-trial. 2. Aged 18-45 years at signing the informed consent form. 3. Childbearing potential subjects: no pregnancy/sperm/egg donation plans; effective contraception.
Exclusion criteria
1. Recent infection (≤2 weeks): pathogen-positive test, systemic antibiotics, or fever \> 38°C. 2. Major trauma/surgery (≤8 weeks) or planned surgery during the study. 3. Drug abuse history or positive urine drug screen. 4. Investigator-assessed suitability concerns: increased risk, compliance issues, or clinical ineligibility.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Time to peak concentration (Tmax) | Day 1 to Day 13. |
| Adverse events (AEs) | Day 1 to Day 20. |
Countries
China
Outcome results
None listed