Healthy Adult VolunteersPhase 1NCT05757596
Study of VSA001 Injection in Chinese Healthy Adult Volunteers
A Phase 1 study testing VSA001 injection in people with Healthy Adult Volunteers, run by Visirna Therapeutics HK Limited at 1 site in China.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- VSA001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to 31 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol.
- Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent.
- Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg.
- In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results.
- Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
- Subjects and their partners must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 3 months after discontinuation of study treatment.
- Fasting serum TGs >80 mg/dL (>0.903 mmol/L) at screening.
Who cannot join
- History or presence of significant or clinically significant diseases/abnormality, including but not limited to cardiac/cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, gallbladder, dermatological, hematological, immunological, neurologic, or psychiatric diseases/abnormality, or the disease that, in the judgement of the investigator, present a safety concern or affects the pharmacokinetic evaluation.
- A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
- Subjects who are with acute exacerbation of any significant acute or chronic disease as judged by the investigator.
- AST and ALT >2×upper limit of normal (ULN) , or total bilirubin >ULN at screening.
- Serum creatinine estimated eGFR < 60 ml/min/1.73 m2 per MDRD formula.
- Cardiac troponin (troponin I) above ULN at Screening.
- Fasting serum TGs >300 mg/dL (>3.38 mmol/L) at screening.
- Presence of other conditions or treatments that may affect the study results and interfere with the subject's participation in the study as assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of a Single Dose of VSA001 Injection in Chinese Healthy Adult Volunteers
This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.
- Conditions
- Healthy Adult Volunteers
- Being tested
- VSA001 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSA001 injectionDrug
The active drug is VSA001 injection. The active pharmaceutical ingredient (API) contained in VSA001 is a synthetic, double-stranded, hepatocyte targeted NAG-conjugated RNAi.
PlaceboDrug
0.9% Saline, volume matched
| Study group | Role | What they receive |
|---|---|---|
| VSA001 injection | Active comparator | A single dose of active drug (VSA001, low or high dose) will be administered by subcutaneous injection on Day 1. Receives: Drug: VSA001 injection |
| Placebo | Placebo comparator | The placebo is normal saline (0.9%) administered subcutaneously; volume matched to the corresponding VSA001 dose volume. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with VSA-01001.
Clinically significant abnormalities in laboratory tests, vital signs, physical examination, 12-lead electrocardiograms (ECG).
Measured: 85 days
Secondary outcomes (7)
Pharmacokinetics parameter: Cmax
Maximum plasma concentration (Cmax)
Measured: 48 hours
Pharmacokinetics parameter: Tmax
Time to maximum plasma concentration (Tmax)
Measured: 48 hours
Pharmacokinetics parameter: AUC0-t
Area under the plasma concentration-time curve from the time 0 to the last quantifiable time point (AUC0-t).
Measured: 48 hours
Pharmacokinetics parameter: t1/2
Half-life (t1/2).
Measured: 48 hours
Pharmacokinetics parameter: CL/F
Apparent clearance (CL/F).
Measured: 48 hours
Pharmacokinetics parameter: Vz/F
Apparent volume of distribution (Vz/F).
Measured: 48 hours
Pharmacodynamic (PD) parameters
Change from baseline over time in fasting serum APOC3 and triglycerides (TGs).
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start17 May 2023
- Primary completion25 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visirna Therapeutics HK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arrowhead Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757596
- Sponsor's protocol ID
- VSA001-1001
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang F, You D, Niu X, Shi J, Li Y, Qi L, Li H. Safety, pharmacokinetics and pharmacodynamics of Plozasiran in Chinese healthy volunteers. Cardiovasc Diabetol. 2025 Oct 15;24(1):399. doi: 10.1186/s12933-025-02929-9.
PubMed 41094680
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of a Single Dose of VSA001 Injection in Chinese Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05757596
- Acronym / sponsor ID
- VSA001-1001
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Visirna Therapeutics HK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Arrowhead Pharmaceuticals
- Study start
- 17 May 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Mar 2023 (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.
This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSA001 injection | Active comparator | Drug: VSA001 injectionA single dose of active drug (VSA001, low or high dose) will be administered by subcutaneous injection on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo is normal saline (0.9%) administered subcutaneously; volume matched to the corresponding VSA001 dose volume. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol.
- Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent.
- Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg.
- In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results.
- Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
Key exclusion criteria (8 listed)
- History or presence of significant or clinically significant diseases/abnormality, including but not limited to cardiac/cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, gallbladder, dermatological, hematological, immunological, neurologic, or psychiatric diseases/abnormality, or the disease that, in the judgement of the investigator, present a safety concern or affects the pharmacokinetic evaluation.
- A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
- Subjects who are with acute exacerbation of any significant acute or chronic disease as judged by the investigator.
- AST and ALT >2×upper limit of normal (ULN) , or total bilirubin >ULN at screening.
- Serum creatinine estimated eGFR < 60 ml/min/1.73 m2 per MDRD formula.
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 |
|---|---|---|
| VSA001 injectionThe active drug is VSA001 injection. The active pharmaceutical ingredient (API) contained in VSA001 is a synthetic, double-stranded, hepatocyte targeted NAG-conjugated RNAi. | Drug | VSA001 injection |
| Placebo0.9% Saline, volume matched | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: 85 days
Incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with VSA-01001. Clinically significant abnormalities in laboratory tests, vital signs, physical examination, 12-lead electrocardiograms (ECG).
7 secondary outcomes
Pharmacokinetics parameter: Cmax
Time frame: 48 hours
Pharmacokinetics parameter: Tmax
Time frame: 48 hours
Pharmacokinetics parameter: AUC0-t
Time frame: 48 hours
Pharmacokinetics parameter: t1/2
Time frame: 48 hours
Pharmacokinetics parameter: CL/F
Time frame: 48 hours
Pharmacokinetics parameter: Vz/F
Time frame: 48 hours
Pharmacodynamic (PD) parameters
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 41094680Wang F, You D, Niu X, Shi J, Li Y, Qi L, Li H. Safety, pharmacokinetics and pharmacodynamics of Plozasiran in Chinese healthy volunteers. Cardiovasc Diabetol. 2025 Oct 15;24(1):399. doi: 10.1186/s12933-025-02929-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 VSA001 injection in people with Healthy Adult Volunteers, run by Visirna Therapeutics HK Limited 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 20 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757596, which also lists 1 linked publication.
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 20 Mar 2025.