Healthy ParticipantsPhase 1NCT06760455
A Safety and Tolerability Study of BPR-30221616 Injection in Healthy Subjects
A Phase 1 study testing BPR-30221616 Injection and Sodium Chloride Injection in people with Healthy Participants, run by Chengdu Brilliant Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BPR-30221616 Injection and Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 5 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaohong Han, 8613810659230, hanxiaohong@pumc.cn
About this study
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
The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in healthy subjects.
- Conditions
- Healthy Participants
- Being tested
- BPR-30221616 Injection, Sodium Chloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPR-30221616 InjectionDrug
BPR-30221616 will be administered by subcutaneous (SC) injection
Sodium Chloride InjectionDrug
Sodium Chloride Injection will be administered by SC injection
| Study group | Role | What they receive |
|---|---|---|
| BPR-30221616 Injection | Experimental | Not described Receives: Drug: BPR-30221616 Injection |
| Sodium Chloride Injection | Placebo comparator | Not described Receives: Drug: Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Participants With Adverse Events (AE)
Measured: Up to Day 360
Incidence of Participants With Serious Adverse Events (SAE)
Measured: Up to Day 360
Incidence of Participants With Clinically Significant laboratory tests, electrocardiogram (ECG), physical examination, vital signs
Measured: Up to Day 360
Secondary outcomes (13)
Maximum plasma concentration （Cmax）of BPR-30221616
Measured: Day 1 through to Day 3
Time to maximum plasma concentration（Tmax） of BPR-30221616
Measured: Day 1 through to Day 3
Area under the plasma concentration-time curve（AUC）of BPR-30221616
Measured: Day 1 through to Day 3
Elimination rate constant (λz) of BPR-30221616
Measured: Day 1 through to Day 3
Elimination half-life (t1/2) of BPR-30221616
Measured: Day 1 through to Day 3
Apparent volume of distribution during terminal phase (Vz/F) of BPR-30221616
Measured: Day 1 through to Day 3
Clearance (CL/F) of BPR-30221616
Measured: Day 1 through to Day 3
Mean residence time from zero to infinity (MRT0-∞) of BPR-30221616
Measured: Day 1 through to Day 3
Cumulative amount of the dose excreted unchanged in urine (Ae) of BPR-30221616
Measured: Day 1 through to Day 3
Cumulative fraction of the dose excreted unchanged in urine (Fe) of BPR-30221616
Measured: Day 1 through to Day 3
Renal clearance(CLr) of BPR-30221616
Measured: Day 1 through to Day 3
Effect of BPR-30221616 on serum transthyretin（TTR） levels as measured by reduction from baseline in serum TTR
Measured: Day 1 through to Day 540
Number of participants who develop serum anti-BPR-30221616 antibodies
Measured: Day 1 through to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start10 Jan 2025
- Primary completion24 Jan 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Brilliant Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760455
- Sponsor's protocol ID
- BPR-30221616-Ⅰ-001
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06760455
- Acronym / sponsor ID
- BPR-30221616-Ⅰ-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chengdu Brilliant Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 24 Jan 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPR-30221616 Injection | Experimental | Drug: BPR-30221616 Injection |
| Sodium Chloride Injection | Placebo comparator | Drug: Sodium Chloride Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPR-30221616 InjectionBPR-30221616 will be administered by subcutaneous (SC) injection | Drug | BPR-30221616 Injection |
| Sodium Chloride InjectionSodium Chloride Injection will be administered by SC injection | Drug | Sodium Chloride Injection |
Primary outcome
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
13 secondary outcomes
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
Number of participants who develop serum anti-BPR-30221616 antibodies
Time frame: Day 1 through to Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPR-30221616 Injection and Sodium Chloride Injection in people with Healthy Participants, run by Chengdu Brilliant Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (China/Beijing+010-69154796, hanxiaohong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Participants With Adverse Events (AE) (time frame: Up to Day 360). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.