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

Suzhou Ribo Life Science

Status and phase

Completed

Phase 1

Conditions

Hyperlipemia

Treatments

Drug: Placebo

Drug: RBD7022

Study type

Interventional

Funder types

Industry

Identifiers

NCT05912296

RBD7022

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

80 participants in 4 patient groups, including a placebo group

RBD7022 SAD experimental group

Experimental group

Description:

Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD7022 on Day 0.

Treatment:

Drug: RBD7022

RBD7022 MAD experimental group

Experimental group

Description:

Subjects in MAD experimental groups will receive one subcutaneous injection of RBD7022 on Day 0 and another subcutaneous injection of RBD7022 on Day 28.

Treatment:

Drug: RBD7022

Placebo SAD group

Placebo Comparator group

Description:

Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 0.

Treatment:

Drug: Placebo

Placebo MAD group

Placebo Comparator group

Description:

Subjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 0 and another subcutaneous injection of placebo on Day 28 .