HyperlipemiaPhase 1NCT05912296
A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022
A Phase 1 study testing RBD7022 in people with Hyperlipemia, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipemia
- What is being tested?
- RBD7022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010
About this study
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
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
- Being tested
- RBD7022, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD7022Drug
Subcutaneously Administered RBD7022 in Healthy Subjects.
RBD7022Drug
Subcutaneously Administered RBD7022 in Healthy Subjects.
PlaceboDrug
Subcutaneously Administered Placebo in Healthys Subject.
PlaceboDrug
Subcutaneously Administered Placebo in Healthys Subject.
| Study group | Role | What they receive |
|---|---|---|
| RBD7022 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD7022 on Day 0. Receives: 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. Receives: Drug: RBD7022 |
| Placebo SAD group | Placebo comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 0. Receives: 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 . Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: SAD up to Day 180; MAD up to Day 208
Secondary outcomes (12)
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)
Measured: SAD up to Day 180; MAD up to Day 208
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).
Measured: SAD up to Day 180; MAD up to Day 208
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
Measured: 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
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
Measured: SAD up to Day 180; MAD up to Day 208
To characterize the pharmacokinetic parameter Cmax
Plasma Maximum concentration (Cmax)
Measured: 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
To characterize the pharmacokinetic parameter Tmax
Time to maximum concentration (Tmax)
Measured: 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
To characterize the pharmacokinetic parameter AUC0-t
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Measured: 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
To characterize the pharmacokinetic parameter t1/2
Half-Life (t1/2)
Measured: 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
To characterize the pharmacokinetic parameter λz
Elimination rate constant (λz)
Measured: 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
To characterize the pharmacokinetic parameter CL/F
Oral clearance (CL/F)
Measured: 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
To characterize the pharmacokinetic parameter Vz/F
Volume of distribution in the terminal elimination period (Vz/F)
Measured: 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
To characterize the pharmacokinetic parameter AUC0-inf
Area under the concentration-time curve from 0 to infinity
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 May 2023
- Primary completion4 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Chen, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912296
- Sponsor's protocol ID
- RBD7022
- Status last verified
- Apr 2025
- First submitted
- 21 May 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05912296
- Acronym / sponsor ID
- RBD7022
- Conditions
- Hyperlipemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RBD7022 SAD experimental group | Experimental | Drug: RBD7022Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD7022 on Day 0. |
| RBD7022 MAD experimental group | Experimental | Drug: RBD7022Subjects in MAD experimental groups will receive one subcutaneous injection of RBD7022 on Day 0 and another subcutaneous injection of RBD7022 on Day 28. |
| Placebo SAD group | Placebo comparator | Drug: PlaceboSubjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 0. |
| Placebo MAD group | Placebo comparator | Drug: PlaceboSubjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 0 and another subcutaneous injection of placebo on Day 28 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD7022Subcutaneously Administered RBD7022 in Healthy Subjects. | Drug | RBD7022 SAD experimental group |
| RBD7022Subcutaneously Administered RBD7022 in Healthy Subjects. | Drug | RBD7022 MAD experimental group |
| PlaceboSubcutaneously Administered Placebo in Healthys Subject. | Drug | Placebo SAD group |
| PlaceboSubcutaneously Administered Placebo in Healthys Subject. | Drug | Placebo MAD group |
Primary outcome
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time frame: SAD up to Day 180; MAD up to Day 208
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
12 secondary outcomes
The serum LDL-C level after subject dosing RBD7022
Time frame: SAD up to Day 180; MAD up to Day 208
The serum PCSK9 level after subject dosing RBD7022
Time frame: SAD up to Day 180; MAD up to Day 208
Other blood lipoprotein and lipid parameters besides LDL-c
Time frame: 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
Time frame: SAD up to Day 180; MAD up to Day 208
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter 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
To characterize the pharmacokinetic parameter AUC0-inf
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Chen, Doctor principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RBD7022 in people with Hyperlipemia, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 (time frame: SAD up to Day 180; MAD up to Day 208). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.