Safety and tolerability assessment of BPR-30221616 injection in healthy individuals

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

This study is testing the safety and how well the BPR-30221616 injection works in healthy adults aged 18 to 65.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06760455 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the BPR-30221616 injection in healthy participants. It involves administering the injection to male and female subjects aged 18 to 65 years who meet specific health criteria. Participants will be monitored for any adverse effects and their overall health will be assessed throughout the study. The goal is to gather data that will inform future studies and potential therapeutic uses of the drug.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 65 who meet specific weight and BMI criteria.

Not a fit: Patients with significant medical histories or conditions that could affect their participation or safety will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety and efficacy data for the BPR-30221616 injection, paving the way for its use in treating various conditions.

How similar studies have performed: While this specific approach is focused on a new drug, similar safety and tolerability studies have historically provided critical data for drug development.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Principal Investigator

Conditions Healthy Participants