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

Suzhou Ribo Life Science Co. Ltd.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hyperlipemia

Interventions

RBD7022

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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