ANX105
BiologicalParticipants will receive single-ascending doses of ANX105 administered by IV infusion.
NCT Number: NCT05288881
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Annexon Investigational Site 02, Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will receive single-ascending doses of ANX105 administered by IV infusion.
Participants will receive matching placebo administered by IV infusion.
Time frame: Up to Week 7
Time frame: Up to Week 7
Blood samples will be obtained to determine the amount of CH50.
Time frame: Baseline, Week 7
Blood samples will be obtained to determine the amount of C1q.
Time frame: Up to Week 7
CSF samples will be obtained to determine the amount of C1q.
Time frame: Up to Week 7
Blood samples will be obtained to determine serum concentrations of ANX105.
Time frame: Up to Week 7
Blood samples will be obtained to determine the Cmax of ANX105.
Time frame: Up to Week 7
Blood samples will be obtained to determine the AUC of ANX105.
Time frame: Up to Week 7
CSF samples will be obtained to determine CSF concentrations of ANX105.
Annexon, Inc.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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