Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
NCT ID: NCT04527718
Last Updated: 2022-11-10
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
40 participants
INTERVENTIONAL
2020-09-09
2021-08-13
Brief Summary
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Detailed Description
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The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
611 dose 1 (45mg) plus placebo
Placebo
placebo as a single SC injection on Day 1;
611
611 as a single SC injection on Day 1;
Cohort 2
611 dose 2 (150mg) plus placebo
Placebo
placebo as a single SC injection on Day 1;
611
611 as a single SC injection on Day 1;
Cohort 3
611 dose 3 (300mg) plus placebo
Placebo
placebo as a single SC injection on Day 1;
611
611 as a single SC injection on Day 1;
Cohort 4
611 dose 4 (450mg) plus placebo
Placebo
placebo as a single SC injection on Day 1;
611
611 as a single SC injection on Day 1;
Cohort 5
611 dose 5 (600mg) plus placebo
Placebo
placebo as a single SC injection on Day 1;
611
611 as a single SC injection on Day 1;
Interventions
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Placebo
placebo as a single SC injection on Day 1;
611
611 as a single SC injection on Day 1;
Eligibility Criteria
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Inclusion Criteria
2. Healthy male and female subjects, non-smokers, 18-55 years of age
3. In the opinion of the investigator, with no significant medical history, and in good health.
4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
5. Subjects are able to follow the study protocol and complete the trial.
Exclusion Criteria
2. Pregnant, or nursing females.
3. HepBsAg or HepCAb positive.
4. Human immunodeficiency virus (HIV) positive.
5. Positive urine drug screen, or cotinine test.
6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
18 Years
55 Years
ALL
Yes
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Covance Dallas Clinical Research Unit
Dallas, Texas, United States
Countries
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Other Identifiers
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SSGJ-611-HV-I-A
Identifier Type: -
Identifier Source: org_study_id
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