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A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects

NCT02612662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-19

No results posted yet for this study

Summary

This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing single doses

Conditions

  • Non-alcoholic Steatohepatitis (NASH)

Interventions

DRUG

AZD4076

Subcutaneous (SC) administration of single ascending doses; there will be no more than 2 mL per syringe/injection

DRUG

Placebo

Subcutaneous (SC) administration of single ascending doses; there will be no more than 2 mL per syringe/injection

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, MDCM, M.Sc, CPI · PAREXEL Early Phase Clinical Unit Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-24
Primary Completion
2017-11-04
Completion
2025-10-27

Countries

  • United States

Study Locations

More Related Trials

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 NCT02612662 on ClinicalTrials.gov