Trials / Completed
CompletedNCT05848440
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
A Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants.
Detailed description
This study will be a Phase I, First-In-Human (FIH), randomised, single-blind, placebo-controlled, single ascending dose (SAD), sequential group study in healthy male and female participants of non- childbearing potential performed at a single study centre. The study consists of 3 parts: * Part A: SAD (up to 5 dose levels) of AZD9550 administered subcutaneous (SC) in healthy participants. * Part B: 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent. * Part C: 1 dose level of AZD9550 administered intravenous (IV) in healthy participants. The study will comprise of: * A Screening Period of maximum 28 days. * A Treatment Period during which participants will be resident at the Clinical Unit from 2 days before (Day -2) investigational medicinal product (IMP\]) administration (Day 1) until at least 7 days (168 hours; Day 8) after IMP administration. * Weekly out-clinic visits on Days 15, 22, 29, and 36. * A Follow-up Visit 6 weeks (Day 43) after the IMP dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD9550 | Participants will be administered AZD9550 subcutaneously. |
| DRUG | AZD9550 | Participants will be administered AZD9550 intravenously. |
| DRUG | Placebo | Participants will be administered matching volumes of placebo subcutaneously or intravenously. |
Timeline
- Start date
- 2023-05-02
- Primary completion
- 2023-11-13
- Completion
- 2023-11-13
- First posted
- 2023-05-08
- Last updated
- 2023-12-11
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05848440. Inclusion in this directory is not an endorsement.