Trials / Completed
CompletedNCT04415671
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
A Phase 1, Dose-escalating Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of AD-214 When Administered Intravenously to Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- AdAlta Limited · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AD-214 | AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis. |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2020-06-19
- Primary completion
- 2021-10-21
- Completion
- 2022-02-08
- First posted
- 2020-06-04
- Last updated
- 2022-05-06
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT04415671. Inclusion in this directory is not an endorsement.