A Single-center, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study to Evaluate the Safety and Tolerability of BPR-30221616 Injection in Healthy Subjects

Chengdu Brilliant Pharmaceutical Co., Ltd.1 site in 1 country48 target enrollmentJanuary 10, 2025

ConditionsHealthy Participants

InterventionsBPR-30221616 Injection Sodium Chloride Injection

DrugsBPR-30221616 Injection Sodium Chloride Injection

Overview

Phase: Phase 1
Intervention: BPR-30221616 Injection
Conditions: Healthy Participants
Sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Incidence of Participants With Adverse Events (AE)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in healthy subjects.

Registry

clinicaltrials.gov

Start Date

January 10, 2025

End Date

December 5, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chengdu Brilliant Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female healthy subjects.
•Age 18 to 65 years.
•Male weight ≥ 50.0 kg ，female weight ≥ 45.0 kg ， BMI ≥18.0 and ≤30.0 kg/m\^
•Females must be non-pregnant and non-lactating.
•Subjects must give informed consent prior to the trial and willing to give written informed consent form.
•Subjects who can communicate reliably with the investigator and comply with all study requirements .

Exclusion Criteria

•Subjects who have a clinically relevant history or presence of neurological,respiratory, gastrointestinal, cardiovascular, haematological, immunological, genitourinary,hepatic,renal, musculoskeletal diseases， or considered unfit for the study by the investigator with new disease within the 7 days prior to dose administration.
•Subjects with a history of serious mental illness.
•Clinically-significant (CS) abnormalities in physical examination, vital signs, electrocardiogram, clinical laboratory examination , chest radiograph and abdominal ultrasound at screening visit.
•Alanine aminotransferase (ALT) \>1.5× normal upper limit (ULN), or aspartate aminotransferase (AST) \>1.5×ULN, or total bilirubin \>1.5×ULN at screening visit.
•Glomerular filtration rate (eGFR) \<90mL/min/1.73m2 at screening visit.
•Vitamin A level \< lower limit of normal (LLN) at screening visit.
•Uncontrolled ventricular arrhythmias, or co-morbidities that may cause prolonged QT.
•Known history of allergic reactions to 2 or more drugs or to N-acetylated galactosamine (GalNAc) or oligonucleotides.
•Subjects who had undergone major surgery within 6 months prior to screening or planned to undergo surgery during the study period, and who had previously undergone surgery that would affect drug absorption, distribution, metabolism, or excretion (except surgery for appendicitis).
•Alcoholic or regular drinking within the 6 months of randomization; Or a positive baseline alcohol breath test.

Arms & Interventions

BPR-30221616 Injection

Intervention: BPR-30221616 Injection

Sodium Chloride Injection

Intervention: Sodium Chloride Injection

Outcomes

Primary Outcomes

Incidence of Participants With Adverse Events (AE)

Time Frame: Up to Day 360

Incidence of Participants With Serious Adverse Events (SAE)

Time Frame: Up to Day 360

Incidence of Participants With Clinically Significant laboratory tests, electrocardiogram (ECG), physical examination, vital signs

Time Frame: Up to Day 360

Secondary Outcomes

Maximum plasma concentration （Cmax）of BPR-30221616(Day 1 through to Day 3)
Time to maximum plasma concentration（Tmax） of BPR-30221616(Day 1 through to Day 3)
Area under the plasma concentration-time curve（AUC）of BPR-30221616(Day 1 through to Day 3)
Elimination rate constant (λz) of BPR-30221616(Day 1 through to Day 3)
Elimination half-life (t1/2) of BPR-30221616(Day 1 through to Day 3)
Apparent volume of distribution during terminal phase (Vz/F) of BPR-30221616(Day 1 through to Day 3)
Clearance (CL/F) of BPR-30221616(Day 1 through to Day 3)
Mean residence time from zero to infinity (MRT0-∞) of BPR-30221616(Day 1 through to Day 3)
Cumulative amount of the dose excreted unchanged in urine (Ae) of BPR-30221616(Day 1 through to Day 3)
Cumulative fraction of the dose excreted unchanged in urine (Fe) of BPR-30221616(Day 1 through to Day 3)
Renal clearance(CLr) of BPR-30221616(Day 1 through to Day 3)
Effect of BPR-30221616 on serum transthyretin（TTR） levels as measured by reduction from baseline in serum TTR(Day 1 through to Day 540)
Number of participants who develop serum anti-BPR-30221616 antibodies(Day 1 through to Day 360)