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Not yet recruitingNCT07074236Updated Jul 24, 2025

Pharmacokinetics and Pharmacodynamics Study

A Phase 1 interventional study of QLC7401 injection and RBD7022 injection in Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C
03

In context

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    QLC7401 injection

    Drug: QLC7401 injection

  • Experimental
    RBD7022 injection

    Drug: RBD7022 injection

Interventions

  • DrugQLC7401 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.

  • DrugRBD7022 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.

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum plasma concentration of QLC7401 and active metabolites.

    Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

  2. AUC

    Area under the concentration-time curve of QLC7401 and active metabolites.

    Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

  3. Tmax

    Time of maximum observed concentration of QLC7401 and active metabolites..

    Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

  4. t1/2

    Terminal elimination half-life of QLC7401 and active metabolites.

    Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

  5. CL/F

    Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites.

    Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

  6. VZ/F

    Apparent volume of distribution after oral administration of QLC7401 and active metabolites.

    Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

07

Study locations

1 site
  • The Affiliated Hospital of Qingdao University.
    Qingdao, China
    • Yu Cao · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07074236
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 20, 2025
Start date
Jul 2025 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
Jul 24, 2025

Study contacts

Yu Cao, doctorate
Contact
Caoyu1767@126.com
0532-82911767
Cheng qian Li, doctorate
Contact
Lichengqian5213@163.com
18661806523

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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