Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06760455

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

Led by Chengdu Brilliant Pharmaceutical Co., Ltd. · Updated on 2025-02-12

48

Participants Needed

1

Research Sites

99 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female healthy subjects.
  • Age 18 to 65 years.
  • Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, BMI between 18.0 and 30.0 kg/m².
  • Females must be non-pregnant and non-lactating.
  • Must give informed consent and agree to study requirements.
  • Able to communicate reliably with investigators and follow study protocol.
Not Eligible

You will not qualify if you...

  • History or presence of significant neurological, respiratory, gastrointestinal, cardiovascular, hematological, immunological, genitourinary, hepatic, renal, or musculoskeletal diseases.
  • History of serious mental illness.
  • Clinically significant abnormalities in physical exam, vital signs, ECG, lab tests, chest X-ray, or abdominal ultrasound at screening.
  • ALT, AST, or total bilirubin levels >1.5 times normal upper limit.
  • Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m².
  • Vitamin A level below normal.
  • Uncontrolled ventricular arrhythmias or conditions causing prolonged QT.
  • Allergic reactions to two or more drugs or to N-acetylated galactosamine or oligonucleotides.
  • Major surgery within 6 months before screening or planned during study; prior surgeries affecting drug processing (except appendicitis surgery).
  • Alcohol use within 6 months before randomization or positive alcohol breath test.
  • Drug abuse history within 12 months or positive drug screen.
  • Smoking more than 5 cigarettes per day.
  • Infection with HIV, syphilis, hepatitis B or C.
  • Blood donation of 400 mL or more within 3 months before dosing or planned donation until 6 months after dosing.
  • Unwillingness to use effective contraception from consent until 12 months after dosing.
  • Use of investigational agents or devices within 3 months before screening.
  • Use of prescription drugs within 4 weeks before randomization.
  • Use of over-the-counter drugs within 7 days before randomization unless deemed clinically irrelevant.
  • Use of oligonucleotides including siRNA or antisense oligonucleotides.
  • Intolerance to subcutaneous injection.
  • Special diet or strenuous activity within 48 hours before dosing.
  • Any physical or mental condition increasing risk or interfering with study adherence or completion.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

P

Principal Investigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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