HyperlipidemiaPhase 1NCT06041165
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401
A Phase 1 study testing JS401 in people with Hyperlipidemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- JS401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 21 Sep 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender;
- Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening> 1.8 mmol/L (70 mg/dL).
Who cannot join
- Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials;
- Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization;
- Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening;
- History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening;
- History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Fangfang Wang, PhD, 8615611963416, doctorfancy@126.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Kinetic Effects in Healthy Volunteers With Normal or Mildly Elevated Triglycerides
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.
- Conditions
- Hyperlipidemia
- Being tested
- JS401, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS401Drug
Single dose of JS401 by subcutaneous (sc) injections
PlaceboDrug
Calculated volume to match active treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental: JS401 injection | Experimental | Not described Receives: Drug: JS401 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Number of Participants with Adverse Events (AEs)
Measured: Up to 112 days post-dose
Secondary outcomes (15)
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration of JS401
Measured: Up to 48 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time to Maximum Plasma Concentration of JS401
Measured: Up to 48 hours post-dose
Terminal Elimination Half-Life (t1/2)
Terminal Elimination Half-Life (t1/2) of JS401
Measured: Up to 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve of JS401
Measured: Up to 48 hours post-dose
Angiopoietin-like 3 (ANGPTL3)
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Triglycerides
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Measured: Up to 112 days post-dose
immunogenic characteristics ADA of JS401
The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed.
Measured: Up to 112 days post-dose
Low-density lipoprotein cholesterol (LDL-C)
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Non-high-density lipoprotein cholesterol (non-HDL-C)
Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Very low-density lipoprotein cholesterol (VLDL-C)
Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline
Measured: Up to 112 days post-dose
High-density lipoprotein cholesterol (HDL-C)
Reduction in Fasting SerumHDL-C from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Lipoprotein (a) (Lp(a))
Reduction in Fasting Lp(a) from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Apolipoprotein B (ApoB)
Reduction in Fasting ApoB from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Apolipoprotein A1 (ApoA1)
Reduction in Fasting ApoA1 from Pre-Dose Baseline
Measured: Up to 112 days post-dose
Q-T interval
Change in QTc from baseline
Measured: Up to 112 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start31 Aug 2023
- Primary completion29 Jun 2024 (estimated)
- Study completion21 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041165
- Sponsor's protocol ID
- JS401-001
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Kinetic Effects in Healthy Volunteers With Normal or Mildly Elevated Triglycerides
- ClinicalTrials.gov ID
- NCT06041165
- Acronym / sponsor ID
- JS401-001
- Conditions
- Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 29 Jun 2024 (estimated)
- Study completion
- 21 Sep 2024 (estimated)
- First posted
- 18 Sep 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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: JS401 injection | Experimental | Drug: JS401 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender;
- Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening> 1.8 mmol/L (70 mg/dL).
Key exclusion criteria (5 listed)
- Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials;
- Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization;
- Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening;
- History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening;
- History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening
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 |
|---|---|---|
| JS401Single dose of JS401 by subcutaneous (sc) injections | Drug | Experimental: JS401 injection |
| PlaceboCalculated volume to match active treatment | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 112 days post-dose
Number of Participants with Adverse Events (AEs)
15 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Up to 48 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to 48 hours post-dose
Terminal Elimination Half-Life (t1/2)
Time frame: Up to 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Up to 48 hours post-dose
Angiopoietin-like 3 (ANGPTL3)
Time frame: Up to 112 days post-dose
Triglycerides
Time frame: Up to 112 days post-dose
immunogenic characteristics ADA of JS401
Time frame: Up to 112 days post-dose
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Up to 112 days post-dose
Non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: Up to 112 days post-dose
Very low-density lipoprotein cholesterol (VLDL-C)
Time frame: Up to 112 days post-dose
High-density lipoprotein cholesterol (HDL-C)
Time frame: Up to 112 days post-dose
Lipoprotein (a) (Lp(a))
Time frame: Up to 112 days post-dose
Apolipoprotein B (ApoB)
Time frame: Up to 112 days post-dose
Apolipoprotein A1 (ApoA1)
Time frame: Up to 112 days post-dose
Q-T interval
Time frame: Up to 112 days post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- 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.
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 JS401 in people with Hyperlipidemia, run by Shanghai Junshi Bioscience 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fugui Wang (8613511074153, fugui_wang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to 112 days post-dose). 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 18 Sep 2023.