NCT02612662

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

A Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4076 Tetracosasodium Following Single-ascending Dose Administration to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a Phase 1, randomized, first-in-human (FIH) study to assess the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium following subcutaneous (SC) administration in healthy male subjects at increasing single doses

Conditions

• Non-alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-24
• Primary completion: 2017-11-04
• Completion: 2025-10-27
• First posted: 2015-11-24
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States