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Recruiting NCT06760455

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

Phase I Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BPR-30221616 Injection, Sodium Chloride Injection.
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug BPR-30221616 Injection
    BPR-30221616 will be administered by subcutaneous (SC) injection
  • Drug Sodium Chloride Injection
    Sodium Chloride Injection will be administered by SC injection

Primary outcome measures

  • 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 outcome measures (12)
  • Maximum plasma concentration （Cmax）of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Time to maximum plasma concentration（Tmax） of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Area under the plasma concentration-time curve（AUC）of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Elimination rate constant (λz) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Elimination half-life (t1/2) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Apparent volume of distribution during terminal phase (Vz/F) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Clearance (CL/F) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Mean residence time from zero to infinity (MRT0-∞) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Cumulative amount of the dose excreted unchanged in urine (Ae) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Cumulative fraction of the dose excreted unchanged in urine (Fe) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Renal clearance(CLr) of BPR-30221616 [Time frame: Day 1 through to Day 3]
  • Effect of BPR-30221616 on serum transthyretin（TTR） levels as measured by reduction from baseline in serum TTR [Time frame: Day 1 through to Day 540]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06760455 · BPR-30221616-Ⅰ-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗