Study S003319

A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants and With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT06703658
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 35
Start: 2024-11-02
Primary completion: 2025-03-13
Lead sponsor: AstraZeneca
Conditions: Healthy Participants; Type 2 Diabetes
Interventions: DRUG:AZD5004(Part A); DRUG:Placebo(Part A); DRUG:AZD5004(Part B); DRUG:Placebo(Part B)
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

PartA: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [From screening (Day -28) to last follow up visit (Day 8)]
PartB: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [From screening (Day -28) to last follow up visit (Day 119 )]

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