HypercholesterolemiaPhase 1NCT03366688
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
A Phase 1 study testing IBI306 in people with Hypercholesterolemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- IBI306
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2017to 5 Nov 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy men or women aged 18 to 55 years old at screening (inclusive）;
- Serum LDL-C concentration between 1.8 mmol/L and 4.9 mmol/L (inclusive）at screening;
- Body mass index between 19 and 28 kg/m2 (inclusive);
- Willing to maintain the current regular diet and physical activity;
- Female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing;
- Without any medical history of serious diseases;
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
Who cannot join
- Breast-feeding or pregnant women;
- History of allergic reaction;
- Previously received any anti-PCSK-9 treatment;
- Vital signs, physical examination, clinical laboratory test, 12-lead ECG, and chest X-ray are abnormal with clinical significance;
- Not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits;
- Any hospitalization within one month before screening, or major surgery within six months before screening, or any other unstable medical condition;
Show all 16Show fewer
- Received an investigational chemical agent within 30 days before dosing；
- Received an investigational biological agent within 90 days before dosing；
- Use of medications including over-the-counter medication within 14 days or less than 5 half-lifes of the agent;
- Use of herb,vitamins or nutraceutical in order to alter serum lipids;
- Positive screen of hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection at screening；
- History or clinical evidence of alcohol or drugs of abuse within 12 months before screening;
- With any consumption of alcohol and caffeinated beverages within 72 hours prior to and during the trial;
- Blood donations or blood loss 200 ml and more within 2 months before screening;
- History of organ transplantation or malignant tumor;
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of IBI306 in Healthy Subjects.
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
Read the detailed description
Ascending dose design includes 6 dose levels （25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg). Tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose. Total duration of the study per subject is 12 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- IBI306, placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI306Drug
Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
placeboDrug
Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
| Study group | Role | What they receive |
|---|---|---|
| IBI306 | Active comparator | Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design Receives: Drug: IBI306 |
| placebo | Placebo comparator | Subcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events（AEs) as assessed by the criteria of National Institute on Aging
Measured: up to 12 weeks
Secondary outcomes (7)
The area under the curve (AUC) of serum concentration of the drug after the administration
Measured: up to 12 weeks
Maximum concentration (Cmax) of the drug after the administration
Measured: up to 12 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration
Measured: up to 12 weeks
The half-life (t1/2) of drug after the administration
Measured: up to 12 weeks
Assessment of serum concentrations of PCSK-9
Measured: up to 12 weeks
Change from baseline in lipid parameters
Measured: up to 12 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start27 Nov 2017
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366688
- Sponsor's protocol ID
- CIBI306A101
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2017
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol with any amendments and statistical analysis plan. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of IBI306 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03366688
- Acronym / sponsor ID
- CIBI306A101
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 8 Dec 2017 (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.
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
Detailed description
Ascending dose design includes 6 dose levels （25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg). Tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose. Total duration of the study per subject is 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI306 | Active comparator | Drug: IBI306Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design |
| placebo | Placebo comparator | Drug: placeboSubcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chinese healthy men or women aged 18 to 55 years old at screening (inclusive）;
- Serum LDL-C concentration between 1.8 mmol/L and 4.9 mmol/L (inclusive）at screening;
- Body mass index between 19 and 28 kg/m2 (inclusive);
- Willing to maintain the current regular diet and physical activity;
- Female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing;
Key exclusion criteria (16 listed)
- Breast-feeding or pregnant women;
- History of allergic reaction;
- Previously received any anti-PCSK-9 treatment;
- Vital signs, physical examination, clinical laboratory test, 12-lead ECG, and chest X-ray are abnormal with clinical significance;
- Not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits;
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 |
|---|---|---|
| IBI306Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV. | Drug | IBI306 |
| placeboCohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV. | Drug | placebo |
Primary outcome
Number of participants with adverse events（AEs) as assessed by the criteria of National Institute on Aging
Time frame: up to 12 weeks
7 secondary outcomes
The area under the curve (AUC) of serum concentration of the drug after the administration
Time frame: up to 12 weeks
Maximum concentration (Cmax) of the drug after the administration
Time frame: up to 12 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration
Time frame: up to 12 weeks
The half-life (t1/2) of drug after the administration
Time frame: up to 12 weeks
Assessment of serum concentrations of PCSK-9
Time frame: up to 12 weeks
Change from baseline in lipid parameters
Time frame: up to 12 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies
Time frame: up to 12 weeks
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 21 Dec 2020.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol with any amendments and statistical analysis plan. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 IBI306 in people with Hypercholesterolemia, run by Innovent Biologics (Suzhou) 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 7 inclusion and 16 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 21 Dec 2020. 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 adverse events（AEs) as assessed by the criteria of National Institute on Aging (time frame: up to 12 weeks). 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 21 Dec 2020.