A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
NCT ID: NCT05147259
Last Updated: 2021-12-07
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
60 participants
INTERVENTIONAL
2021-11-29
2022-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cohort one: Low dose
Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
HR011408 injection
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Cohort two: Medium dose
Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
HR011408 injection
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Cohort three: high dose
Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
HR011408 injection
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Interventions
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HR011408 injection
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index 18.0-26.0kg/m2(both inclusive)
3. Body weight ≥50.0kg(male),≥45.0kg(female)
4. Fasting serum/plasma glucose \<6.1mmol/L
Exclusion Criteria
2. Participated in any drug or medical device-related clinical trial within 3 months before screening.
3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration
4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.
5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.
18 Years
55 Years
ALL
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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HR011408-101
Identifier Type: -
Identifier Source: org_study_id
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