Back to resultsA Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022
Primary Purpose
Hyperlipemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
RBD7022
RBD7022
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipemia
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
RBD7022 SAD experimental group
RBD7022 MAD experimental group
Placebo SAD group
Placebo MAD group
Arm Description
Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD7022 on Day 0.
Subjects in MAD experimental groups will receive one subcutaneous injection of RBD7022 on Day 0 and another subcutaneous injection of RBD7022 on Day 28.
Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 0.
Subjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 0 and another subcutaneous injection of placebo on Day 28 .
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The serum LDL-C level after subject dosing RBD7022
measure the LDL-C level in blood by lab examination and eveluate the effect of RBD7022 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to treatment/Baseline LDL-c Level)
The serum PCSK9 level after subject dosing RBD7022
measure the pcsk9 level in blood by lab examination and eveluate the effect of RBD7022 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to treatment/Baseline PCSK9 Level).
Other blood lipoprotein and lipid parameters besides LDL-c
measure other blood lipoprotein and lipid parameters besides LDL-c in blood by lab examination and eveluate % change and absolute change in other lipoprotein and lipid parameters（TC、TG、Lp (a)、HDL-C、non HDL-C、Apo B、Apo A1、Apo A 1/ Apo B ratio） from baseline up to Day 208
The effect of RBD7022 monotherapy or RBD7022 combination with statin in patients with elevated LDL-C
measure the LDL-C and pcsk9 level in blood by lab examination and assess % change and absolute change in LDL-c and PCSK9 from baseline up to Day 208
To characterize the pharmacokinetic parameter Cmax
Plasma Maximum concentration (Cmax)
To characterize the pharmacokinetic parameter Tmax
Time to maximum concentration (Tmax)
To characterize the pharmacokinetic parameter AUC0-t
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
To characterize the pharmacokinetic parameter t1/2
Half-Life (t1/2)
To characterize the pharmacokinetic parameter λz
Elimination rate constant (λz)
To characterize the pharmacokinetic parameter CL/F
Oral clearance (CL/F)
To characterize the pharmacokinetic parameter Vz/F
Volume of distribution in the terminal elimination period (Vz/F)
To characterize the pharmacokinetic parameter AUC0-inf
Area under the concentration-time curve from 0 to infinity
Full Information
NCT ID
NCT05912296
First Posted
May 21, 2023
Last Updated
June 12, 2023
Sponsor
Suzhou Ribo Life Science Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05912296
Brief Title
A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Ribo Life Science Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RBD7022 SAD experimental group
Arm Type
Experimental
Arm Description
Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD7022 on Day 0.
Arm Title
RBD7022 MAD experimental group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo SAD group
Arm Type
Placebo Comparator
Arm Description
Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 0.
Arm Title
Placebo MAD group
Arm Type
Placebo Comparator
Arm 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 .
Intervention Type
Drug
Intervention Name(s)
RBD7022
Intervention Description
Subcutaneously Administered RBD7022 in Healthy Subjects.
Intervention Type
Drug
Intervention Name(s)
RBD7022
Intervention Description
Subcutaneously Administered RBD7022 in Healthy Subjects.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneously Administered Placebo in Healthys Subject.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneously Administered Placebo in Healthys Subject.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Description
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
Time Frame
SAD up to Day 180; MAD up to Day 208
Secondary Outcome Measure Information:
Title
The serum LDL-C level after subject dosing RBD7022
Description
measure the LDL-C level in blood by lab examination and eveluate the effect of RBD7022 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to treatment/Baseline LDL-c Level)
Time Frame
SAD up to Day 180; MAD up to Day 208
Title
The serum PCSK9 level after subject dosing RBD7022
Description
measure the pcsk9 level in blood by lab examination and eveluate the effect of RBD7022 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to treatment/Baseline PCSK9 Level).
Time Frame
SAD up to Day 180; MAD up to Day 208
Title
Other blood lipoprotein and lipid parameters besides LDL-c
Description
measure other blood lipoprotein and lipid parameters besides LDL-c in blood by lab examination and eveluate % change and absolute change in other lipoprotein and lipid parameters（TC、TG、Lp (a)、HDL-C、non HDL-C、Apo B、Apo A1、Apo A 1/ Apo B ratio） from baseline up to Day 208
Time Frame
SAD up to Day 180; MAD up to Day 208
Title
The effect of RBD7022 monotherapy or RBD7022 combination with statin in patients with elevated LDL-C
Description
measure the LDL-C and pcsk9 level in blood by lab examination and assess % change and absolute change in LDL-c and PCSK9 from baseline up to Day 208
Time Frame
SAD up to Day 180; MAD up to Day 208
Title
To characterize the pharmacokinetic parameter Cmax
Description
Plasma Maximum concentration (Cmax)
Time Frame
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
Title
To characterize the pharmacokinetic parameter Tmax
Description
Time to maximum concentration (Tmax)
Time Frame
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
Title
To characterize the pharmacokinetic parameter AUC0-t
Description
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Time Frame
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
Title
To characterize the pharmacokinetic parameter t1/2
Description
Half-Life (t1/2)
Time Frame
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
Title
To characterize the pharmacokinetic parameter λz
Description
Elimination rate constant (λz)
Time Frame
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
Title
To characterize the pharmacokinetic parameter CL/F
Description
Oral clearance (CL/F)
Time Frame
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
Title
To characterize the pharmacokinetic parameter Vz/F
Description
Volume of distribution in the terminal elimination period (Vz/F)
Time Frame
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
Title
To characterize the pharmacokinetic parameter AUC0-inf
Description
Area under the concentration-time curve from 0 to infinity
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Chen, Doctor
Phone
86 010 69154794
Email
chenrui04@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Chen, Doctor
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Chen, Doctor
Phone
8601069154794
Email
chenrui04@126.com
12. IPD Sharing Statement
Learn more about this trial
A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022
We'll reach out to this number within 24 hrs