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

Last updated: April 28, 2025
Sponsor: Suzhou Ribo Life Science Co. Ltd.
Overall Status: Completed

Phase

1

Condition

High Cholesterol (Hyperlipidemia)

Hypercholesterolemia

Elevated Triglycerides (Hypertriglyceridemia)

Treatment

Placebo

RBD7022

Clinical Study ID

NCT05912296
RBD7022
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 andprovide written informed consent.

  • The clinical laboratory examination of the subjects was within the normal range, orabnormal but had no clinical significance as judged by the investigators, and didnot affect the study results;

  • Vital signs, physical examination, ECG, ultrasound showed normal or abnormal but noclinically significant as determined by the investigator.

Exclusion

Exclusion Criteria:

  • With a clear history of primary diseases of major organs, the subject is notsuitable 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 subjectunsuitable for enrollment or could interfere with the subject's participation in orcompletion of the study.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 30, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 010
    China

    Site Not Available

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