HyperlipemiaPhase 1NCT05432544
Safety and Tolerability of SHR-1918 in Healthy Subjects
A Phase 1 study testing SHR-1918 in people with Hyperlipemia, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects. 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?
- SHR-1918
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2022to 12 Dec 2023
- 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
- Age ≥18 and ≤65 on the date of signing the informed consent, males or females;
- 1.7 mmol/L≤TG≤5.6 mmol/L，2.6 mmol/L≤LDL-C<4.9 mmol/L;
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Who cannot join
- -
- 1.History of disease or treatment for:
- Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs;
- Malignncy;
- Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases;
- History of any drug use prior to screening or within 2 weeks prior to baseline
Show all 15Show fewer
- 2.Any one of the following tests at screening :
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN
- Creatine kinase (CK) exceeding 3 times the upper limit of normal (ULN)
- 3.General:
- History of drug or substance abuse;
- Average of 5 or more cigarettes per day during the 4 weeks prior to screening;
- History of blood donation within 3 months prior to screening, or severe blood loss (≥400 mL blood loss), or received a blood transfusion within 4 weeks;
- Vaccination within 2 weeks prior to screening or planned during the course of the trial
- 4.The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 511447
About this study
Official title: A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects
The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.
- Conditions
- Hyperlipemia
- Being tested
- SHR-1918, SHR-1918 placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1918Drug
Ascending dose
SHR-1918 placeboDrug
Ascending dose
| Study group | Role | What they receive |
|---|---|---|
| SAD, SHR-1918 | Experimental | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection Receives: Drug: SHR-1918 |
| SAD, SHR-1918 placebo | Placebo comparator | Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection Receives: Drug: SHR-1918 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the number of subjects with adverse events (AEs)
Measured: up to day 190
To assess the number of subjects with serious adverse events (SAEs)
Measured: up to day 190
Secondary outcomes (16)
To assess AUC0-t
Measured: up to day 190
To assess AUC0-∞
Measured: up to day 190
To assess Tmax
Measured: up to day 190
To assess Cmax
Measured: up to day 190
To assess t1/2
Measured: up to day 190
To assess CL/F
Measured: up to day 190
To assess 、V/F.
Measured: up to day 190
To assess LDL-C
Measured: up to day 190
To assess TC
Measured: up to day 190
To assess HDL-C
Measured: up to day 190
To assess TG
Measured: up to day 190
To assess ApoB
Measured: up to day 190
To assess ApoA1
Measured: up to day 190
To assess Lp(a)
Measured: up to day 190
To assess VLDL-C.
Measured: up to day 190
To assess ADA(or/and Nab).
Measured: up to day 190
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start27 Jun 2022
- Primary completion11 Dec 2023 (estimated)
- Study completion12 Dec 2023 (estimated)
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 HyperlipemiaStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe 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
- Model description
- SHR-1918 injection compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432544
- Sponsor's protocol ID
- SHR-1918-101
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qin R, Ye L, Duan L, Li M, He W, Mei X, Li D, Jin R, Lv C, Zhu M, Wang S, Xie Z. SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Pharmacokinet. 2025 Aug;64(8):1245-1253. doi: 10.1007/s40262-025-01539-8. Epub 2025 Jun 27.
PubMed 40576753
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05432544
- Acronym / sponsor ID
- SHR-1918-101
- Conditions
- Hyperlipemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 11 Dec 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 27 Jun 2022 (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.
The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1918 injection compared with placebo
| Arm | Type | Receives |
|---|---|---|
| SAD, SHR-1918 | Experimental | Drug: SHR-1918Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection |
| SAD, SHR-1918 placebo | Placebo comparator | Drug: SHR-1918 placeboUp to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 and ≤65 on the date of signing the informed consent, males or females;
- 1.7 mmol/L≤TG≤5.6 mmol/L，2.6 mmol/L≤LDL-C<4.9 mmol/L;
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Key exclusion criteria (15 listed)
- -
- Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs;
- Malignncy;
- Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases;
- History of any drug use prior to screening or within 2 weeks prior to baseline
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-1918Ascending dose | Drug | SAD, SHR-1918 |
| SHR-1918 placeboAscending dose | Drug | SAD, SHR-1918 placebo |
Primary outcome
To assess the number of subjects with adverse events (AEs)
Time frame: up to day 190
To assess the number of subjects with serious adverse events (SAEs)
Time frame: up to day 190
16 secondary outcomes
To assess AUC0-t
Time frame: up to day 190
To assess AUC0-∞
Time frame: up to day 190
To assess Tmax
Time frame: up to day 190
To assess Cmax
Time frame: up to day 190
To assess t1/2
Time frame: up to day 190
To assess CL/F
Time frame: up to day 190
To assess 、V/F.
Time frame: up to day 190
To assess LDL-C
Time frame: up to day 190
To assess TC
Time frame: up to day 190
To assess HDL-C
Time frame: up to day 190
To assess TG
Time frame: up to day 190
To assess ApoB
Time frame: up to day 190
To assess ApoA1
Time frame: up to day 190
To assess Lp(a)
Time frame: up to day 190
To assess VLDL-C.
Time frame: up to day 190
To assess ADA(or/and Nab).
Time frame: up to day 190
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 40576753Qin R, Ye L, Duan L, Li M, He W, Mei X, Li D, Jin R, Lv C, Zhu M, Wang S, Xie Z. SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Pharmacokinet. 2025 Aug;64(8):1245-1253. doi: 10.1007/s40262-025-01539-8. Epub 2025 Jun 27.
- Individual participant dataSharing planned: Undecided
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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.
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-1918 in people with Hyperlipemia, run by Beijing Suncadia Pharmaceuticals 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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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?
Results are not available in the source record.
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?
To assess the number of subjects with adverse events (AEs) (time frame: up to day 190). The study lists 2 primary outcomes in all. 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 NCT05432544, 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 6 Jul 2023.