Single Ascending Dose Study of ANX105

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288881
• Other study ID #: ANX105-NHV-01
• Secondary ID: 2021-005510-33
• Status: Recruiting
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2022
• Source: Annexon, Inc.
• Contact: Study Coordinator
• Phone: 1-650-822-5500
• Email: clinicaltrials[@]annexonbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-center, first-in-human, randomized, double-blind, placebo-controlled single ascending dose study in healthy adult participants. This study consists of an approximately 6 to 10 weeks Screening Period and a 7-week treatment period composed of a 6-day confinement period (Day -1 to Day 5), and outpatient visits up to Day 43 (Week 7).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key 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 -1.

• Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.

Key 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 -1.

• 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 -1.

• Hospitalization during the 4 weeks prior to Screening.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• ANX105
Participants will receive single-ascending doses of ANX105 administered by IV infusion.

Drug:
• Placebo
Participants will receive matching placebo administered by IV infusion.

Locations

Country	Name	City	State
Netherlands	Annexon Investigational Site 01	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Annexon, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Treatment-Emergent Adverse Events		Up to Week 7
Secondary	Amount of Serum Total Hemolytic Complement (CH50)	Blood samples will be obtained to determine the amount of CH50.	Up to Week 7
Secondary	Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum	Blood samples will be obtained to determine the amount of C1q.	Baseline, Week 7
Secondary	Amount of C1q in Cerebrospinal fluid (CSF)	CSF samples will be obtained to determine the amount of C1q.	Up to Week 7
Secondary	Serum Concentrations of ANX105	Blood samples will be obtained to determine serum concentrations of ANX105.	Up to Week 7
Secondary	Maximum Observed Serum Concentration (Cmax) of ANX105	Blood samples will be obtained to determine the Cmax of ANX105.	Up to Week 7
Secondary	Area Under the ANX009 Serum Concentration-Time Curve (AUC)	Blood samples will be obtained to determine the AUC of ANX105.	Up to Week 7
Secondary	CSF Concentrations of ANX105	CSF samples will be obtained to determine CSF concentrations of ANX105.	Up to Week 7