HealthyPhase 1NCT05521269
Dose Study of ANX1502 in Healthy Volunteers
A Phase 1 study testing ANX1502 in people with Healthy, run by Annexon, Inc. at 1 site in Netherlands.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ANX1502
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jun 2022to 19 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 Exceptions can be made for individuals with childhood or remote disorders that are no longer active.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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.
- Conditions
- Healthy
- Being tested
- ANX1502, Placebo
- Keywords
- healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX1502Drug
ANX1502 is a prodrug of ANX1439.
PlaceboDrug
Placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| ANX1502 SAD | Experimental | Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo. Receives: Drug: ANX1502; Drug: Placebo |
| ANX1502 MAD | Experimental | Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days. Receives: Drug: ANX1502; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
Measured: Day 1 (after dosing) through Day 29
Secondary outcomes (5)
Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502
Measured: Predose up Day 29
Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Measured: Predose up Day 29
Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Measured: Predose up to Day 29
Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Measured: Predose up Day 29
Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Measured: Predose up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start27 Jun 2022
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Bandman, Study director, Annexon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521269
- Sponsor's protocol ID
- ANX1502-NHV-01
- Other IDs
- 2022-000594-21
- Status last verified
- Dec 2024
- First submitted
- 28 Aug 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05521269
- Acronym / sponsor ID
- ANX1502-NHV-01
- Conditions
- Healthy
- Keywords
- healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.
| Arm | Type | Receives |
|---|---|---|
| ANX1502 SAD | Experimental | Drug: ANX1502, Drug: PlaceboParticipants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo. |
| ANX1502 MAD | Experimental | Drug: ANX1502, Drug: PlaceboParticipants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANX1502ANX1502 is a prodrug of ANX1439. | Drug | ANX1502 MAD, ANX1502 SAD |
| PlaceboPlacebo comparator. | Drug | ANX1502 MAD, ANX1502 SAD |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
Time frame: Day 1 (after dosing) through Day 29
5 secondary outcomes
Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502
Time frame: Predose up Day 29
Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Time frame: Predose up Day 29
Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Time frame: Predose up to Day 29
Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Time frame: Predose up Day 29
Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Time frame: Predose up to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Bandman study director
Annexon, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANX1502 in people with Healthy, run by Annexon, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502 (time frame: Day 1 (after dosing) through Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.