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A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers

NCT04076540 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-07-17

Study results available
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Summary

This is a Phase I, first-in-human (FIH), single-center, randomized, double-blind, placebo controlled, single ascending dose, sequential group study in healthy vasectomized male and female subjects of non-childbearing potential, aged 18 to 65 years.

Conditions

  • Smoking Cessation

Interventions

DRUG

AZD4041

Administration by Oral syringe

DRUG

Placebo

Administration by Oral syringe

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eolas Therapeutics INC.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Rebecca N. Wood-Horrall, MD · PPD Development, LP

  • Darin Brimhall, DO, FACP · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2022-01-02
Completion
2022-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT04076540 on ClinicalTrials.gov