Clinical trial NCT05521269: Dose Study of ANX1502 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-30
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.


Eligibility criteria: 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.
* MAD cohorts only: Documented history of vaccinations within 5 years of Screening 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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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 study drug administration 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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
timeFrame: Day 1 (after dosing) through Day 29
Secondary outcomes:
measure: Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502
timeFrame: Predose up Day 29
measure: Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
timeFrame: Predose up Day 29
measure: Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
timeFrame: Predose up to Day 29
measure: Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
timeFrame: Predose up Day 29
measure: Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
timeFrame: Predose up to Day 29
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Annexon Investigational Site 01
Study officials:
affiliation: Annexon, Inc.
name: Olga Bandman
role: STUDY_DIRECTOR
References: