Clinical trial NCT05912296: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipemia
Lead sponsor: Suzhou Ribo Life Science Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: SAD up to Day 180; MAD up to Day 208
Secondary outcomes:
measure: The serum LDL-C level after subject dosing RBD7022
timeFrame: SAD up to Day 180; MAD up to Day 208
measure: The serum PCSK9 level after subject dosing RBD7022
timeFrame: SAD up to Day 180; MAD up to Day 208
measure: Other blood lipoprotein and lipid parameters besides LDL-c
timeFrame: SAD up to Day 180; MAD up to Day 208
measure: The effect of RBD7022 monotherapy or RBD7022 combination with statin in patients with elevated LDL-C
timeFrame: SAD up to Day 180; MAD up to Day 208
measure: To characterize the pharmacokinetic parameter Cmax
timeFrame: 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
measure: To characterize the pharmacokinetic parameter Tmax
timeFrame: 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
measure: To characterize the pharmacokinetic parameter AUC0-t
timeFrame: 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
measure: To characterize the pharmacokinetic parameter t1/2
timeFrame: 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
measure: To characterize the pharmacokinetic parameter λz
timeFrame: 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
measure: To characterize the pharmacokinetic parameter CL/F
timeFrame: 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
measure: To characterize the pharmacokinetic parameter Vz/F
timeFrame: 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
measure: To characterize the pharmacokinetic parameter AUC0-inf
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Rui Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: