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Tests treatment safety and results for Healthy Participants
Official title A Safety and Tolerability Study of BPR-30221616 Injection in Healthy Subjects
ClinicalTrials.gov ID: NCT06760455
What this study is testing
What is BPR-30221616 Injection?
BPR-30221616 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in healthy subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Male and female healthy people.
- 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.
- people must give informed consent prior to the trial and willing to give written informed consent form.
You likely can't join if
- people who have a clinically relevant history or presence of neurological,respiratory, gastrointestinal, cardiovascular, haematological...
- people with a history of serious mental illness.
- Clinically-significant (CS) abnormalities in physical examination, vital signs, electrocardiogram, clinical laboratory examination , chest radiograph...
- Alanine aminotransferase (ALT) \>1.5× normal upper limit (ULN), or aspartate aminotransferase (AST) \>1.5×ULN, or total bilirubin \>1.5×ULN at...
- Glomerular filtration rate (eGFR) \<90mL/min/1.73m2 at screening visit.
- Vitamin A level \< lower limit of normal (LLN) at screening visit.
See the full eligibility criteria
- Male and female healthy people.
- 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.
- people must give informed consent prior to the trial and willing to give written informed consent form.
- people who can communicate reliably with the investigator and comply with all study requirements .
- people who have a clinically relevant history or presence of neurological,respiratory, gastrointestinal, cardiovascular, haematological, immunological, genitourinary,hepatic,renal, musculoskeletal diseases， or...
- people 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.
- people 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...
- Alcoholic or regular drinking within the 6 months of randomization; Or a positive baseline alcohol breath test.
- people 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.
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.