NCT05912296

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Suzhou Ribo Life Science Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-03-04
• Completion: 2025-03-31
• First posted: 2023-06-22
• Last updated: 2025-05-01

Locations

1 site across 1 country: China