HypercholesteremiaPhase 1NCT03634436
The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
A Phase 1 study testing SHR-1209 in people with Hypercholesteremia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesteremia
- What is being tested?
- SHR-1209
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2018to 28 May 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 and ≤45 years old;
- The body mass index (BMI) should be 19 or greater and < 28kg/m2, the male weigh ≥50.0kg and <90.0kg, and the female weigh ≥45.0kg and <90.0kg;
- Serum LDL-C concentration≥2.0mmol/L and < 4.1mmol/L;
- Fasting triglycerides < 2.3 mmol/L;
- The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
- Signed informed consent.
Who cannot join
- Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
- A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
- Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
- Subjects with previous malignant tumor diseases;
- 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc
Trial locations and contacts
1 site in 1 country.
China1 site
FuWai Hospital , Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects.
The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.
Read the detailed description
32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
- Conditions
- Hypercholesteremia
- Being tested
- SHR-1209, Placebo
- Keywords
- SHR-1209 Phase 1
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1209Drug
Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | A single subcutaneous injection of SHR-1209 dose 1 versus placebo Receives: Drug: SHR-1209; Drug: Placebo |
| Cohort 2 | Experimental | A single subcutaneous injection of SHR-1209 dose 2 versus placebo Receives: Drug: SHR-1209; Drug: Placebo |
| Cohort 3 | Experimental | A single subcutaneous injection of SHR-1209 dose 3 versus placebo Receives: Drug: SHR-1209; Drug: Placebo |
| Cohort 4 | Experimental | A single subcutaneous injection of SHR-1209 dose 4 versus placebo Receives: Drug: SHR-1209; 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
Measured: Pre-dose to 150 days after dose administration
Secondary outcomes (5)
Assessment of PK parameter-time to maximum concentration (Tmax)
Measured: Pre-dose to 150 days after dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Measured: Pre-dose to 150 days after dose administration
Assessment of PK parameter-area under curve (AUC)
Measured: Pre-dose to 150 days after dose administration
Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Measured: Pre-dose to 150 days after dose administration
Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline
Measured: Pre-dose to 150 days after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start30 Aug 2018
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesteremiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634436
- Sponsor's protocol ID
- SHR-1209-101
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.
PubMed 40587053
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03634436
- Acronym / sponsor ID
- SHR-1209-101
- Conditions
- Hypercholesteremia
- Keywords
- SHR-1209 Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 16 Aug 2018 (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 Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects.
The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.
Detailed description
32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR-1209, Drug: PlaceboA single subcutaneous injection of SHR-1209 dose 1 versus placebo |
| Cohort 2 | Experimental | Drug: SHR-1209, Drug: PlaceboA single subcutaneous injection of SHR-1209 dose 2 versus placebo |
| Cohort 3 | Experimental | Drug: SHR-1209, Drug: PlaceboA single subcutaneous injection of SHR-1209 dose 3 versus placebo |
| Cohort 4 | Experimental | Drug: SHR-1209, Drug: PlaceboA single subcutaneous injection of SHR-1209 dose 4 versus placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥18 and ≤45 years old;
- The body mass index (BMI) should be 19 or greater and < 28kg/m2, the male weigh ≥50.0kg and <90.0kg, and the female weigh ≥45.0kg and <90.0kg;
- Serum LDL-C concentration≥2.0mmol/L and < 4.1mmol/L;
- Fasting triglycerides < 2.3 mmol/L;
- The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
Key exclusion criteria (7 listed)
- Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
- A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
- Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
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 |
|---|---|---|
| SHR-1209Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboPharmaceutical form: lyophilized formulation Route of administration: subcutaneous | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Number of participants with adverse events
Time frame: Pre-dose to 150 days after dose administration
5 secondary outcomes
Assessment of PK parameter-time to maximum concentration (Tmax)
Time frame: Pre-dose to 150 days after dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Time frame: Pre-dose to 150 days after dose administration
Assessment of PK parameter-area under curve (AUC)
Time frame: Pre-dose to 150 days after dose administration
Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Time frame: Pre-dose to 150 days after dose administration
Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline
Time frame: Pre-dose to 150 days after dose administration
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 3 Aug 2022.
- Derived from this study: PubMed 40587053Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.
Related trials for Hypercholesteremia
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 SHR-1209 in people with Hypercholesteremia, run by Jiangsu HengRui Medicine 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 7 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 3 Aug 2022. 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. 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 (time frame: Pre-dose to 150 days after dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634436, which also lists 1 linked publication.
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 3 Aug 2022.