NCT06311760

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants

A Phase I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, And Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.

Detailed description

This is a First-time-in-human (FTiH) trial. Eligible participants will be randomized to receive AZD0292 or Placebo. Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention. The study will comprise: 1. A Screening Period of maximum 28 days. 2. A Treatment Period 3. A Follow-up Period from Day 3 to Day 16 4. An extended Follow-up Period from Day 17 to Day 61 Participants will be involved in this study for a maximum duration of 13 weeks.

Conditions

• Healthy Participants Study

Interventions

Type	Name	Description
DRUG	AZD0292	AZD0292 will be administered as single dose via IV infusion.
DRUG	Placebo	Placebo will be administered as IV infusion.

Timeline

• Start date: 2024-04-09
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2024-03-15
• Last updated: 2025-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study