A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers
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
1 other identifier
interventional
72
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2020
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2020
CompletedStudy Start
First participant enrolled
May 11, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedAugust 18, 2021
August 1, 2021
12 months
May 10, 2020
August 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of SAEs and treatment-related adverse events
Incidence of SAEs and treatment-related severe AEs
Baseline through Study Completion (up to Day 14)
Secondary Outcomes (2)
Maximum Plasma Concentration (Cmax) will be assessed
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
Area Under the Curve (AUC) will be assessed
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
Study Arms (2)
ALZ002 DS
EXPERIMENTALSAD: 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
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cmax clinical research
Adelaide, 5000, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2020
First Posted
May 19, 2020
Study Start
May 11, 2020
Primary Completion
April 28, 2021
Study Completion
June 15, 2021
Last Updated
August 18, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share