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

NCT05912296 | Completed Phase 1

• 1 other identifier: RBD7022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  SAD up to Day 180; MAD up to Day 208

Secondary Outcomes (12)

• The serum LDL-C level after subject dosing RBD7022

  SAD up to Day 180; MAD up to Day 208

• The serum PCSK9 level after subject dosing RBD7022

  SAD up to Day 180; MAD up to Day 208

• Other blood lipoprotein and lipid parameters besides LDL-c

  SAD up to Day 180; MAD up to Day 208

• The effect of RBD7022 monotherapy or RBD7022 combination with statin in patients with elevated LDL-C

  SAD up to Day 180; MAD up to Day 208

• To characterize the pharmacokinetic parameter Cmax

  SAD: within 60 min before dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24, 48 and 72 hours after dosing; MAD: within 60 minutes before day 0 and day 28 dosing, and at 15min, 30min, 1, 2, 4, 6, 8,12, 24 ,48 and 72 hours after Day 0 and day 28 dosing

Study Arms (4)

RBD7022 SAD experimental group

EXPERIMENTAL

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

Drug: RBD7022

RBD7022 MAD experimental group

EXPERIMENTAL

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

Drug: RBD7022

Placebo SAD group

PLACEBO COMPARATOR

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

Drug: Placebo

Placebo MAD group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RBD7022 DRUG

Subcutaneously Administered RBD7022 in Healthy Subjects.

RBD7022 SAD experimental group

Placebo DRUG

Subcutaneously Administered Placebo in Healthys Subject.

Placebo SAD group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Ribo Life Science Co. Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rui Chen, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 22, 2023
• Study Start: May 30, 2023
• Primary Completion: March 4, 2025
• Study Completion: March 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)