Back to resultsSafety and Tolerability of SHR-1918 in Healthy Subjects
Primary Purpose
Hyperlipemia
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-1918
SHR-1918 placebo
Sponsored by
About this trial
This is an interventional other trial for Hyperlipemia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
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
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.
Sites / Locations
- The Second Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SAD, SHR-1918
SAD, SHR-1918 placebo
Arm Description
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection
Outcomes
Primary Outcome Measures
To assess the number of subjects with adverse events (AEs)
To assess the number of subjects with serious adverse events (SAEs)
Secondary Outcome Measures
To assess AUC0-t
To assess AUC0-∞
To assess Tmax
To assess Cmax
To assess t1/2
To assess CL/F
To assess 、V/F.
To assess LDL-C
To assess TC
To assess HDL-C
To assess TG
To assess ApoB
To assess ApoA1
To assess Lp(a)
To assess VLDL-C.
To assess ADA(or/and Nab).
Full Information
NCT ID
NCT05432544
First Posted
June 21, 2022
Last Updated
July 3, 2023
Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05432544
Brief Title
Safety and Tolerability of SHR-1918 in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipemia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
SHR-1918 injection compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAD, SHR-1918
Arm Type
Experimental
Arm Description
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection
Arm Title
SAD, SHR-1918 placebo
Arm Type
Placebo Comparator
Arm Description
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection
Intervention Type
Drug
Intervention Name(s)
SHR-1918
Intervention Description
Ascending dose
Intervention Type
Drug
Intervention Name(s)
SHR-1918 placebo
Intervention Description
Ascending dose
Primary Outcome Measure Information:
Title
To assess the number of subjects with adverse events (AEs)
Time Frame
up to day 190
Title
To assess the number of subjects with serious adverse events (SAEs)
Time Frame
up to day 190
Secondary Outcome Measure Information:
Title
To assess AUC0-t
Time Frame
up to day 190
Title
To assess AUC0-∞
Time Frame
up to day 190
Title
To assess Tmax
Time Frame
up to day 190
Title
To assess Cmax
Time Frame
up to day 190
Title
To assess t1/2
Time Frame
up to day 190
Title
To assess CL/F
Time Frame
up to day 190
Title
To assess 、V/F.
Time Frame
up to day 190
Title
To assess LDL-C
Time Frame
up to day 190
Title
To assess TC
Time Frame
up to day 190
Title
To assess HDL-C
Time Frame
up to day 190
Title
To assess TG
Time Frame
up to day 190
Title
To assess ApoB
Time Frame
up to day 190
Title
To assess ApoA1
Time Frame
up to day 190
Title
To assess Lp(a)
Time Frame
up to day 190
Title
To assess VLDL-C.
Time Frame
up to day 190
Title
To assess ADA(or/and Nab).
Time Frame
up to day 190
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
-
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
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.
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511447
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safety and Tolerability of SHR-1918 in Healthy Subjects
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