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NCT06132360CompletedPhase 1

the Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C

A Phase 1, Randomized, Single-blinded, Placebo-controlled, Single-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C

Source: ClinicalTrials.gov · Last updated 3 Apr 2025

Brief summary (registry, in English)

This is a randomized, placebo-controlled, single ascending-dose (SAD) study of administered SC to adult subjects with elevated LDL-C. Subjects who have signed an Ethics Committee (EC)-approved informed consent form (ICF) and have met all the protocol eligibility criteria during screening may be enrolled into the study.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
32 (actual)
First submitted
6 Nov 2023
Start date
18 Jan 2024
Primary completion date
2 Jul 2024
Lead sponsor
Shanghai Rona Therapeutics Co., Ltd.
NCT number
NCT06132360

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 32
  • From 18 Jan 2024 to the primary completion date, 2 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received any medication including, but not limited to, statins, ezetimibe, or lipid-altering nutrients within 30 days prior to screening, or PCSK9 antibody within 90 days prior to screening, or any LDL-C-lowering siRNA therapy within 12 months prior to screening

Other illness

  • History of multiple drug allergies or allergic reactions to oligonucleotides or N-acetylglucosamine (GalNAc)
  • Any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment or may interfere with the subject's participation in or completion of the study. This includes, but is not limited to: history or presence of cardiovascular disease (including peripheral arterial and cerebrovascular disease); diabetes mellitus (except for diabetes mellitus of pregnancy in remission); cerebrovascular accidents; and abnormal thyroid function.

Lab values

  • Known underlying disease or medical condition that may have a potential impact on general safety assessment, lipid metabolism, or glucose metabolism, or surgical condition (including, but not limited to, bariatric surgery) that, in the opinion of the investigator, may interfere with the interpretation of the results of the clinical study
  • Subjects with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 1.5 times the upper limit of normal (ULN) at the time of screening (one repeat of the screening assay is permitted) with clinically significant ALT and/or AST \> ULN and ≤ 1.5 times the ULN as determined by the investigator

Who the study is looking for

  • Male and female subjects, aged 18 to 60 years, inclusive
  • Body mass index between 18 and 32 kg/m2, inclusive, with body weight \> 45 kg for females and \>50 kg for males
  • Serum LDL-C ≥100 mg/dL (2.6 mmol/L) at screening and Day -1
  • Fasting triglycerides \< 400 mg/dL (\<4.52 mmol/L) at screening and Day -1

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Third Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.