A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers
NCT ID: NCT04392830
Last Updated: 2021-08-18
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
2020-05-11
2021-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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ALZ002 DS
SAD: 6 cohorts of subjects are planned to be orally dosed, ranging from 15 mg - 800 mg.
MAD: 3 cohorts of subjects are planned to be orally dosed once or twice daily for 7 consecutive days, ranging from 300 mg - 600 mg.
ALZ002 DS
Administered orally
Placebo
Placebo
Placebo
Administered orally
Interventions
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ALZ002 DS
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index \> 18.5 and \< 30.0 kg/m2, and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening visit.
* Capable of consent.
Exclusion Criteria
* Positive urine drug screen, alcohol breath test, or urine cotinine test
* History of significant allergic reactions to any drug.
* Participation in a clinical research study involving the administration of an investigational or marketed drug or device
* History of clinically significant opportunistic infection
* Presence of fever (body temperature \> 38°C)
18 Years
55 Years
ALL
Yes
Sponsors
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AnnJi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cmax clinical research
Adelaide, , Australia
Countries
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Other Identifiers
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ALZ002-101
Identifier Type: -
Identifier Source: org_study_id
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