Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2023-07-19
2024-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 2
A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 3
A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 4
A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 5
A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 6
A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 7
A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 8
A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 9
A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 10
A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 11
A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Cohort 12
A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.
SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Interventions
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SHR-2001
Subcutaneous injection, single dose or multiple doses.
Placebo
Subcutaneous injection, single dose or multiple doses.
Eligibility Criteria
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Inclusion Criteria
2. Age 18 \~ 55 years old (including boundary value), male or female;
3. Weight ≥ 45 kg, body mass index (BMI) ranging 19 \~ 28 kg/m2 (including boundary value);
4. Participants who are overtly healthy as determined by medical history and physical examination.;
5. Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.
Exclusion Criteria
2. Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
3. Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;
18 Years
55 Years
ALL
Yes
Sponsors
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Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Countries
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Other Identifiers
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SHR-2001-101
Identifier Type: -
Identifier Source: org_study_id
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