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
50 participants
INTERVENTIONAL
2024-07-24
2025-01-02
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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single ascending dose (SAD) cohorts
Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo
HRS-9813
Specified dose on specified days
Placebo
Specified dose on specified days
multiple ascending dose (MAD) cohorts
Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo
HRS-9813
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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HRS-9813
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 18-55 (adult healthy volunteers);
3. Body mass index (BMI) between 19 and 26 kg/m2;
4. Normal Electrocardiogram (ECG);
5. Men and women of childbearing potential must agree to take effective contraceptive methods.
Exclusion Criteria
2. History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
3. Seated systolic blood pressure (SBP) of \<90 mmHg or seated diastolic blood pressure (DBP) of \<60 mmHg;
4. Patients with orthostatic hypotension;
5. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
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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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Other Identifiers
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HRS-9813-101
Identifier Type: -
Identifier Source: org_study_id
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