Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-CPhase 1NCT07074236
Pharmacokinetics and Pharmacodynamics Study
A Phase 1 study testing QLC7401 injection and RBD7022 injection in people with Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C
- What is being tested?
- QLC7401 injection and RBD7022 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Jan 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
- Males and females who are 18 to 65 years of age.
- BMI is within the range of 18~28 kg/m2 (including the boundary value).
- LDL-C is within the range of 1.8 mmol/L (70 mg/dl) and 4.1 mmol/L (158 mg/dl) (including the lower boundary value). TG is less than or equal to 4.5 mmol/L (400 mg/dl).
- TC is less than 6.2 mmol/L (239 mg/dl).
Who cannot join
- Subjects with confirmed diabetes.
- Subjects with severe active psychiatric illness or disorder.
- eGFR is less than 90 ml/min.
- AST is equal to or above the 2 fold of upper limit of normal value or TBIL is equal to or above the 1.5 fold of upper limit of normal value.
- Subjects administered prescription drugs 14 days before the first drug administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Single-center, Parallel Study in Subjects With Normal or Elevated Low-density Lipoprotein Cholesterol Level to Compare the Pharmacokinetics and Pharmacodynamics of the Two Formulations of QLC7401 Injection
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change.
- Being tested
- QLC7401 injection, RBD7022 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC7401 injectionDrug
QLC7401 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. QLC7401 injection was introduced by Qilu Pharmaceutical Co., Ltd. from Suzhou Ruibo Biotechnology Co., Ltd. QLC7401 injection was produced by Qilu Pharmaceutical Co., Ltd.
RBD7022 injectionDrug
RBD7022 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. RBD7022 injection was produced by Suzhou Ruibo Biotechnology Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| QLC7401 injection | Experimental | Not described Receives: Drug: QLC7401 injection |
| RBD7022 injection | Experimental | Not described Receives: Drug: RBD7022 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration of QLC7401 and active metabolites.
Measured: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
AUC
Area under the concentration-time curve of QLC7401 and active metabolites.
Measured: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Tmax
Time of maximum observed concentration of QLC7401 and active metabolites..
Measured: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
t1/2
Terminal elimination half-life of QLC7401 and active metabolites.
Measured: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
CL/F
Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites.
Measured: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
VZ/F
Apparent volume of distribution after oral administration of QLC7401 and active metabolites.
Measured: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-CStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074236
- Sponsor's protocol ID
- QLC7401-102
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-center, Parallel Study in Subjects With Normal or Elevated Low-density Lipoprotein Cholesterol Level to Compare the Pharmacokinetics and Pharmacodynamics of the Two Formulations of QLC7401 Injection
- ClinicalTrials.gov ID
- NCT07074236
- Acronym / sponsor ID
- QLC7401-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Jul 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 compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLC7401 injection | Experimental | Drug: QLC7401 injection |
| RBD7022 injection | Experimental | Drug: RBD7022 injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females who are 18 to 65 years of age.
- BMI is within the range of 18~28 kg/m2 (including the boundary value).
- LDL-C is within the range of 1.8 mmol/L (70 mg/dl) and 4.1 mmol/L (158 mg/dl) (including the lower boundary value). TG is less than or equal to 4.5 mmol/L (400 mg/dl).
- TC is less than 6.2 mmol/L (239 mg/dl).
Key exclusion criteria (5 listed)
- Subjects with confirmed diabetes.
- Subjects with severe active psychiatric illness or disorder.
- eGFR is less than 90 ml/min.
- AST is equal to or above the 2 fold of upper limit of normal value or TBIL is equal to or above the 1.5 fold of upper limit of normal value.
- Subjects administered prescription drugs 14 days before the first drug administration.
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 |
|---|---|---|
| QLC7401 injectionQLC7401 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. QLC7401 injection was introduced by Qilu Pharmaceutical Co., Ltd. from Suzhou Ruibo Biotechnology Co., Ltd. QLC7401 injection was produced by Qilu Pharmaceutical Co., Ltd. | Drug | QLC7401 injection |
| RBD7022 injectionRBD7022 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. RBD7022 injection was produced by Suzhou Ruibo Biotechnology Co., Ltd. | Drug | RBD7022 injection |
Primary outcome
Cmax
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Maximum plasma concentration of QLC7401 and active metabolites.
AUC
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Area under the concentration-time curve of QLC7401 and active metabolites.
Tmax
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Time of maximum observed concentration of QLC7401 and active metabolites..
t1/2
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Terminal elimination half-life of QLC7401 and active metabolites.
CL/F
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites.
VZ/F
Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Apparent volume of distribution after oral administration of QLC7401 and active metabolites.
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 24 Jul 2025.
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 QLC7401 injection and RBD7022 injection in people with Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C, run by Qilu 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 4 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: opening soon, as of the sponsor's last update on 24 Jul 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. 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 Yu Cao, doctorate (0532-82911767, Caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose). The study lists 6 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 24 Jul 2025.