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

NCT06760455 | Recruiting Phase 1

• 1 other identifier: BPR-30221616-Ⅰ-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Incidence of Participants With Adverse Events (AE)

  Up to Day 360

• Incidence of Participants With Serious Adverse Events (SAE)

  Up to Day 360

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

  Up to Day 360

Secondary Outcomes (13)

• 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

Other Outcomes (2)

• Effect of BPR-30221616 on serum Vitamin A levels as measured by reduction from baseline in serum Vitamin A

  Day 1 through to Day 540

• Effect of BPR-30221616 on serum Retinol-Binding Protein（RBP） levels as measured by reduction from baseline in serum RBP

  Day 1 through to Day 540

Study Arms (2)

BPR-30221616 Injection

EXPERIMENTAL

Drug: BPR-30221616 Injection

Sodium Chloride Injection

PLACEBO COMPARATOR

Drug: Sodium Chloride Injection

Interventions

BPR-30221616 Injection DRUG

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

BPR-30221616 Injection

Sodium Chloride Injection DRUG

Sodium Chloride Injection will be administered by SC injection

Sodium Chloride Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Brilliant Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Principal Investigator

CONTACT

China/Beijing+010-69154796; hanxiaohong@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 6, 2025
• Study Start: January 10, 2025
• Primary Completion: January 24, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-12

Locations

CN (1)