Dose Study of ANX1502 in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521269
• Other study ID #: ANX1502-NHV-01
• Secondary ID: 2022-000594-21
• Status: Recruiting
• Phase: Phase 1
• Start date: June 27, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• 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 evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key Inclusion Criteria:

• Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laboratory tests.

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

Key Exclusion Criteria:

• History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.

• History of any autoimmune disease

• History of meningitis or septicemia

• Clinically significant infection within 30 days prior to Day -1 that required medical intervention.

• Known genetic deficiencies of the complement cascade system or immunodeficiency.

• Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.

• Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .

• History of prior other malignancy that could affect compliance with the protocol or interpretation of results

• Has clinically significant laboratory abnormalities or abnormal ECG

• History of splenectomy.

• Antinuclear antibodies titer =1:160 at Screening.

• Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ANX1502
ANX1502 is a prodrug of ANX1439.
• Placebo
Placebo comparator.

Locations

Country	Name	City	State
Netherlands	Annexon Investigational Site 01	Groningen

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 with Treatment Emergent Adverse Events (TEAEs) After A Single Dose (With or Without Food) and Multiple Doses of ANX1502		Day 1 (after dosing) through Day 29
Secondary	Plasma ANX1502 and ANX1439 Concentrations After A Single Dose (With or Without Food) and Multiple Doses of ANX1502		Predose up Day 29
Secondary	Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502		Predose up Day 29
Secondary	Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502		Predose up to Day 29
Secondary	Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502		Predose up Day 29
Secondary	Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose (With or Without Food) and Multiple Doses of ANX1502		Predose up to Day 29