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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04392830
Ethics application status
Date submitted
10/05/2020
Date registered
19/05/2020

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04392830