Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2025-07-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QLC7401 injection
QLC7401 injection
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 injection
RBD7022 injection
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.
Interventions
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QLC7401 injection
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 injection
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Affiliated Hospital of Qingdao University.
Qingdao, , China
Countries
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Central Contacts
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Facility Contacts
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Yu Cao
Role: primary
Other Identifiers
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QLC7401-102
Identifier Type: -
Identifier Source: org_study_id
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