Safety and Tolerability in Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneous ANX009 in Normal Healthy Volunteers (NHV)
The purpose of this study is to evaluate the safety, tolerability, pharmakokinetics and pharmacodynamics of single and repeated doses of ANX009
In this first in human, phase 1, randomized, double-blind, placebo-controlled study, single and multiple ascending doses of ANX009 or placebo will be administered to 48 healthy subjects. Single Ascending Dose (SAD): Each SAD subject will participate for approximately 4 weeks (3 nights in-clinic confinement). Multiple Ascending Dose: Each MAD subject will participate for approximately 6 weeks (17 nights in-clinic confinement). All subjects will be contacted (in clinic visit or phone call) 6 months after study completion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03672604 -
A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04783545 -
Phase I Study of VLX-1005 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01955564 -
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
|
Phase 1 | |
| Completed |
NCT04034784 -
Discrete(TM) Safety Clinical Trial GLAD-01
|
N/A | |
| Terminated |
NCT03010046 -
Single Dose Study of ANX005 in Healthy Volunteers
|
Phase 1 |