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Completed

NCT Number: NCT05912296

A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022

This is a randomized, single blind, placebo controlled, single center phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of subcutaneously administered RBD7022 in participants with normal or elevated LDL-c cholesterol. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in participants. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information in each cohort.

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Key information

Conditions

Hyperlipemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects, aged 18 to 65 years, inclusive
  • Body mass index between 17 and 28 kg/m2 , inclusive
  • LDL-C normal or elevated at screening and baseline.
  • Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
  • The clinical laboratory examination of the subjects was within the normal range, or abnormal but had no clinical significance as judged by the investigators, and did not affect the study results;
  • Vital signs, physical examination, ECG, ultrasound showed normal or abnormal but no clinically significant as determined by the investigator.

Exclusion criteria

  • With a clear history of primary diseases of major organs, the subject is not suitable to participate in this study considered by the investigator;
  • Diagnosis of diabetes mellitus;
  • Pregnant or breastfeeding women;
  • Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.

Treatment and study plan

RBD7022

Drug

Subcutaneously Administered RBD7022 in Healthy Subjects.

Placebo

Drug

Subcutaneously Administered Placebo in Healthys Subject.

Primary outcomes

  1. Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: SAD up to Day 180; MAD up to Day 208

    By the examination of vital signs, physical examination, 12-lead electrocardiogram (ECG), and laboratory examination, the investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0

Secondary outcomes

  1. The serum LDL-C level after subject dosing RBD7022

    Time frame: SAD up to Day 180; MAD up to Day 208

    measure the LDL-C level in blood by lab examination and eveluate the effect of RBD7022 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to treatment/Baseline LDL-c Level)

  2. The serum PCSK9 level after subject dosing RBD7022

    Time frame: SAD up to Day 180; MAD up to Day 208

    measure the pcsk9 level in blood by lab examination and eveluate the effect of RBD7022 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to treatment/Baseline PCSK9 Level).

  3. Other blood lipoprotein and lipid parameters besides LDL-c

    Time frame: SAD up to Day 180; MAD up to Day 208

    measure other blood lipoprotein and lipid parameters besides LDL-c in blood by lab examination and eveluate % change and absolute change in other lipoprotein and lipid parameters（TC、TG、Lp (a)、HDL-C、non HDL-C、Apo B、Apo A1、Apo A 1/ Apo B ratio） from baseline up to Day 208

  4. The effect of RBD7022 monotherapy or RBD7022 combination with statin in patients with elevated LDL-C

    Time frame: SAD up to Day 180; MAD up to Day 208

    measure the LDL-C and pcsk9 level in blood by lab examination and assess % change and absolute change in LDL-c and PCSK9 from baseline up to Day 208

  5. To characterize the pharmacokinetic parameter Cmax

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Plasma Maximum concentration (Cmax)

  6. To characterize the pharmacokinetic parameter Tmax

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Time to maximum concentration (Tmax)

  7. To characterize the pharmacokinetic parameter AUC0-t

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Area under the concentration-time curve from 0 to the collection time t (AUC0-t)

  8. To characterize the pharmacokinetic parameter t1/2

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Half-Life (t1/2)

  9. To characterize the pharmacokinetic parameter λz

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Elimination rate constant (λz)

  10. To characterize the pharmacokinetic parameter CL/F

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Oral clearance (CL/F)

  11. To characterize the pharmacokinetic parameter Vz/F

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Volume of distribution in the terminal elimination period (Vz/F)

  12. To characterize the pharmacokinetic parameter AUC0-inf

    Time frame: SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

    Area under the concentration-time curve from 0 to infinity

Sponsors and collaborators

Lead sponsor

Suzhou Ribo Life Science Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Single Blind, Placebo Controlled, Single Center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of Subcutaneously Administered RBD7022 in Participants With Normal or Elevated LDL-c Cholesterol

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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