NCT05288881CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Annexon, Inc.
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Number of Participants Who Experienced Treatment-Emergent Adverse Events
Study Overview
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- •Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -
- •Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.
Exclusion Criteria
- •Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
- •Significant allergies to humanized monoclonal antibodies.
- •Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -
- •Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening.
- •Have poor venous access limiting phlebotomy.
- •Donation or loss of > 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -
- •Hospitalization during the 4 weeks prior to Screening.
Arms & Interventions
ANX105
Experimental
Intervention: ANX105 (Biological)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Time Frame: Up to Week 7
Secondary Outcomes
- Amount of Serum Total Hemolytic Complement (CH50)(Up to Week 7)
- Amount of C1q in Cerebrospinal fluid (CSF)(Up to Week 7)
- Maximum Observed Serum Concentration (Cmax) of ANX105(Up to Week 7)
- Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum(Baseline, Week 7)
- Serum Concentrations of ANX105(Up to Week 7)
- Area Under the ANX105 Serum Concentration-Time Curve (AUC)(Up to Week 7)
- CSF Concentrations of ANX105(Up to Week 7)
Investigators
Study Sites (2)
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