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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UNKNOWN
PHASE1
68 participants
INTERVENTIONAL
2021-11-01
2022-12-31
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
BASIC_SCIENCE
DOUBLE
Study Groups
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HS-20094 (Single dose)
Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants.
HS-20094
Administrated SC
HS-20094 (Multiple doses)
Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants.
HS-20094
Administrated SC
Placebo (Single dose)
Placebo administered SC once in healthy participants.
Placebo
Administrated SC
Placebo (Multiple doses)
Placebo administered SC once weekly for four weeks in healthy participants.
Placebo
Administrated SC
Interventions
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HS-20094
Administrated SC
Placebo
Administrated SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects agree to use an effective method of contraception and avoid sperm or egg donation for the duration of the study and for 6 months following the last dose of investigational product
3. Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to last visit, and to avoid strenuous exercise
Exclusion Criteria
2. Subjects have a medical history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematology or metabolic abnormalities (e.g., repeated hypoglycemia for unknown reasons) and are judged not suitable for this study by the investigator.
3. Subjects with abnormal screening vital signs, physical examination, laboratory examination or 12 lead electrocardiogram results with clinical significance
4. Have a history of drug allergy, or known allergies to HS-20094, glucagon-like peptide (GLP)-1 analogs, or glucose-dependent insulinotropic polypeptide (GIP) receptor agonism
5. Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3 months prior to screening, or are likely to receive these treatments during the study period
6. Have a history of digestive disease (e.g., gastroesophageal reflux disease, gallbladder disease, or chronic enteritis) that may affect gastrointestinal adverse events assessment or any other gastrointestinal disease (e.g., gastric bypass surgery, pyloric stenosis, etc.) that may affect gastric emptying
7. Have a diet, weight loss treatment or significant lifestyle changes prior to 30 days of administration
18 Years
55 Years
ALL
Yes
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yimin Cui
Role: PRINCIPAL_INVESTIGATOR
Beijing University First Hospital
Locations
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Beijing University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-20094-101
Identifier Type: -
Identifier Source: org_study_id
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