HealthyPhase 1NCT05288881
Single Ascending Dose Study of ANX105
A Phase 1 study testing ANX105 in people with Healthy, run by Annexon, Inc. at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ANX105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesNetherlands
- Study dates
- 28 Feb 2022to 19 Jun 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Annexon Investigational Site 02
Groningen
Annexon Investigational Site 01
Leiden
About this study
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
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
- Conditions
- Healthy
- Being tested
- ANX105, Placebo
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX105Biological
Participants will receive single-ascending doses of ANX105 administered by IV infusion.
PlaceboDrug
Participants will receive matching placebo administered by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| ANX105 | Experimental | Not described Receives: Biological: ANX105 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Measured: Up to Week 7
Secondary outcomes (7)
Amount of Serum Total Hemolytic Complement (CH50)
Blood samples will be obtained to determine the amount of CH50.
Measured: Up to Week 7
Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum
Blood samples will be obtained to determine the amount of C1q.
Measured: Baseline, Week 7
Amount of C1q in Cerebrospinal fluid (CSF)
CSF samples will be obtained to determine the amount of C1q.
Measured: Up to Week 7
Serum Concentrations of ANX105
Blood samples will be obtained to determine serum concentrations of ANX105.
Measured: Up to Week 7
Maximum Observed Serum Concentration (Cmax) of ANX105
Blood samples will be obtained to determine the Cmax of ANX105.
Measured: Up to Week 7
Area Under the ANX105 Serum Concentration-Time Curve (AUC)
Blood samples will be obtained to determine the AUC of ANX105.
Measured: Up to Week 7
CSF Concentrations of ANX105
CSF samples will be obtained to determine CSF concentrations of ANX105.
Measured: Up to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start28 Feb 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Placebo-controlled single ascending dose study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Bandman, MD, Study director, Annexon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288881
- Sponsor's protocol ID
- ANX105-NHV-01
- Other IDs
- 2021-005510-33
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 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 Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05288881
- Acronym / sponsor ID
- ANX105-NHV-01
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 21 Mar 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 assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled single ascending dose study.
| Arm | Type | Receives |
|---|---|---|
| ANX105 | Experimental | Biological: ANX105 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (7 listed)
- 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.
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 |
|---|---|---|
| ANX105Participants will receive single-ascending doses of ANX105 administered by IV infusion. | Biological | ANX105 |
| PlaceboParticipants will receive matching placebo administered by IV infusion. | Drug | Placebo |
Primary outcome
Number of Participants Who Experienced Treatment-Emergent Adverse Events
Time frame: Up to Week 7
7 secondary outcomes
Amount of Serum Total Hemolytic Complement (CH50)
Time frame: Up to Week 7
Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum
Time frame: Baseline, Week 7
Amount of C1q in Cerebrospinal fluid (CSF)
Time frame: Up to Week 7
Serum Concentrations of ANX105
Time frame: Up to Week 7
Maximum Observed Serum Concentration (Cmax) of ANX105
Time frame: Up to Week 7
Area Under the ANX105 Serum Concentration-Time Curve (AUC)
Time frame: Up to Week 7
CSF Concentrations of ANX105
Time frame: Up to Week 7
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 19 Aug 2024.
- Individual participant dataSharing planned: No
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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, MD study director
Annexon, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANX105 in people with Healthy, run by Annexon, Inc. at 2 sites 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 3 inclusion and 7 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Who Experienced Treatment-Emergent Adverse Events (time frame: Up to Week 7). 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 19 Aug 2024.