A Safety and Tolerability Study of BPR-30221616 Injection in Healthy Subjects

NCT ID: NCT06760455

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2026-12-05

Brief Summary

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

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BPR-30221616 Injection

Group Type: EXPERIMENTAL

BPR-30221616 Injection

Intervention Type: DRUG

BPR-30221616 will be administered by subcutaneous (SC) injection

Sodium Chloride Injection

Group Type: PLACEBO_COMPARATOR

Sodium Chloride Injection

Intervention Type: DRUG

Sodium Chloride Injection will be administered by SC injection

Interventions

BPR-30221616 Injection

BPR-30221616 will be administered by subcutaneous (SC) injection

Intervention Type: DRUG

Sodium Chloride Injection

Sodium Chloride Injection will be administered by SC injection

Intervention Type: DRUG

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^2.
• 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.
• Subjects who have a history of drug abuse within the 12 months of screening or have a positive baseline drug screening result.
• Smoking >5 cigarettes a day.
• Known human immunodeficiency virus (HIV) ,Treponema pallidum Antibody (TP-Ab),hepatitis B surface antigen (HBsAg)or hepatitis C virus (HCV) infection at screening visit.
• Subjects who have donated 400 mL or more of blood within the 3 months prior to dose administration or plan to donate until 6 months after dose administration.
• From the signing of informed consent, throughout the study until 12 months after dose administration , unwilling to use appropriate and effective contraceptions.
• Received an investigational agent or device intervention within 3 months of screening.
• Received prescription drugs within 4 weeks of randomization.
• Received over-the-counter drugs(unless deemed not clinically relevant by the investigator) within 7 days of randomization.
• Received any oligonucleotides[including small interfering ribonucleic acid(siRNA) and antisense oligonucleotides].
• Intolerance to subcutaneous injection.
• Had a special diet (such as grapefruit and products containing grapefruit, chocolate, any food containing caffeine or rich in xanthines (such as animal liver)) or had strenuous activity within 48 hours prior to dose administration , or with other factors affecting drug absorption, distribution, metabolism, excretion.
• Any physical or mental illness or condition that, as determined by the study physician, is likely to increase the risk of the study, interfere with the subject's adherence to the protocol, or interfere with the subject's completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chengdu Brilliant Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Principal Investigator

Role: CONTACT

hanxiaohong@pumch.cn

China/Beijing+010-69154796

Facility Contacts

Xiaohong Han

Role: primary

hanxiaohong@pumc.cn

8613810659230

Other Identifiers

BPR-30221616-Ⅰ-001

Identifier Type: -

Identifier Source: org_study_id