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

NCT05912296 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-01

No results posted yet for this 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.

Conditions

  • Hyperlipemia

Interventions

DRUG

RBD7022

Subcutaneously Administered RBD7022 in Healthy Subjects.

DRUG

RBD7022

Subcutaneously Administered RBD7022 in Healthy Subjects.

DRUG

Placebo

Subcutaneously Administered Placebo in Healthys Subject.

DRUG

Placebo

Subcutaneously Administered Placebo in Healthys Subject.

Sponsors & Collaborators

  • Suzhou Ribo Life Science Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rui Chen, Doctor · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-03-04
Completion
2025-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912296 on ClinicalTrials.gov