Status:
COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers
Lead Sponsor:
AnnJi Pharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALZ002 DS.
Eligibility Criteria
Inclusion
- Healthy male and/or non-childbearing potential female subjects, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age at screening.
- 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
- Any clinically significant abnormality or abnormal laboratory test results
- 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)
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04392830
Start Date
May 11 2020
End Date
June 15 2021
Last Update
August 18 2021
Active Locations (1)
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1
Cmax clinical research
Adelaide, Australia, 5000