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Multiple Ascending Dose Study of ALZ-801

NCT04157712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-11-19

No results posted yet for this study

Summary

Phase I, single-center, double-blind, randomized, placebo-controlled, parallel-group study of the safety, tolerability, and pharmacokinetics (PK) in plasma and urine, of multiple ascending doses of ALZ-801 (capsule, Part 1; prototype tablet Part 2) and the primary metabolite in healthy male or female subjects.

Conditions

  • Alzheimer Disease

Interventions

DRUG

ALZ-801 or matching placebo

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Alzheon Inc.

    lead INDUSTRY

Principal Investigators

  • Pui Leung, MD · Quotient Clinical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-26
Primary Completion
2016-07-04
Completion
2016-07-04
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04157712 on ClinicalTrials.gov