Study identifier:D5590C00001
ClinicalTrials.gov identifier:NCT02612662
EudraCT identifier:N/A
CTIS identifier:N/A
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
Non-alcoholic steatohepatitis (NASH)
Phase 1
Yes
AZD4076, Placebo
Male
40
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) | 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 |
Experimental: Cohort 2 Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) | 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 |
Experimental: Cohort 3 Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) | 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 |
Experimental: Cohort 4 Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) | 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 |
Experimental: Cohort 5 Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) | 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 |
Experimental: Cohort 6 Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) | 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 |