Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A- AD-214 SAD in Healthy Volunteers | Experimental |
| |
| Part A-Placebo SAD in Healthy Volunteers | Placebo Comparator |
| |
| Part B-AD-214 MAD in Healthy Volunteers | Experimental |
| |
| Part B-Placebo MAD in Healthy Volunteers | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-214 | Biological | AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment | SAD Part A- 28 days. MAD Part B - 57 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Ltd | Randwick | New South Wales | 2031 | Australia | ||
| CMAX Clinical Research Pty Ltd |
Not provided
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
SAD Part A in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) MAD Part B in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| Placebo | Other | Placebo |
|
| Adelaide |
| South Australia |
| 5000 |
| Australia |