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A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07

NCT06194552 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-01-08

No results posted yet for this study

Summary

This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted.

Conditions

  • Alzheimer Disease

Interventions

DRUG

NTRX-07

Investigational orally administered CB2 agonist

DRUG

Placebo

Matched placebo administered orally

Sponsors & Collaborators

  • CRU Early Phase Unit Kistarcsa

    collaborator UNKNOWN

  • NeuroTherapia, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2023-05-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States
  • Hungary

Study Locations

More Related Trials

Entities

Drugs

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 NCT06194552 on ClinicalTrials.gov