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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04392830




Registration number
NCT04392830
Ethics application status
Date submitted
10/05/2020
Date registered
19/05/2020
Date last updated
18/08/2021

Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD-MAD) of ALZ002 DS in Healthy Volunteers
Secondary ID [1] 0 0
ALZ002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALZ002 DS
Treatment: Drugs - Placebo

Experimental: 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.

Placebo Comparator: Placebo - Placebo


Treatment: Drugs: ALZ002 DS
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of SAEs and treatment-related adverse events
Timepoint [1] 0 0
Baseline through Study Completion (up to Day 14)
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) will be assessed
Timepoint [1] 0 0
predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose
Secondary outcome [2] 0 0
Area Under the Curve (AUC) will be assessed
Timepoint [2] 0 0
predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cmax clinical research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AnnJi Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04392830
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04392830