Healthy Volunteers (HV)Phase 1NCT07673601
A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants
A Phase 1 study testing Adimanebart IV, Adimanebart SC - formulation A and Adimanebart SC - formulation B in people with Healthy Volunteers (HV) and Healthy Volunteer, run by argenx at 1 site in Canada.
Trial summary
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (HV), Healthy Volunteer
- What is being tested?
- Adimanebart IV, Adimanebart SC - formulation A and Adimanebart SC - formulation B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
- Has a body weight between 60 and 100 kg and a BMI between 18.5 and 30 kg/m2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight <60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg/m2, inclusive, at screening and on day -1 for part 2.
- Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
Who cannot join
- Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and/or food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.
- Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Altasciences
Montreal, H3P 3P1
Gaetano Morelli, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.
The participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.
Participants will be in the study for approximately up to 24 weeks.
- Conditions
- Healthy Volunteers (HV), Healthy Volunteer
- Being tested
- Adimanebart IV, Adimanebart SC - formulation A, Adimanebart SC - formulation B, Adimanebart SC - formulation C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adimanebart IVBiological
Intravenous infusion of adimanebart IV
Adimanebart SC - formulation ABiological
Subcutaneous administration of Adminanebart SC
Adimanebart SC - formulation BBiological
Subcutaneous administration of Adminanebart SC
Adimanebart SC - formulation CBiological
Subcutaneous administration of Adminanebart SC
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Adimanebart IV | Experimental | Participants randomized to receive adimanebart IV Receives: Biological: Adimanebart IV |
| Part 1 - Adimanebart SC (formulation A) | Experimental | Participants randomized to receive adimanebart SC Receives: Biological: Adimanebart SC - formulation A |
| Part 2 - Adimanebart SC (formulation A) in lower body weights | Experimental | Participants with body weight < 60 kg will receive adimanebart SC Receives: Biological: Adimanebart SC - formulation A |
| Part 2 - Adimanebart SC (formulation A) in higher body weights | Experimental | Participants with body weight between 100 and 130 kg will receive adimanebart SC Receives: Biological: Adimanebart SC - formulation A |
| Part 3 - Adimanebart SC (formulation B) | Experimental | Participants randomized to receive adimanebart SC formulation B Receives: Biological: Adimanebart SC - formulation B |
| Part 3 - Adimanebart SC (formulation C) | Experimental | Participants randomized to receive adimanebart SC formulation C Receives: Biological: Adimanebart SC - formulation C |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
AUC0-inf = area under the concentration-time curve from time 0 to infinity
Measured: Up to 20 weeks
Secondary outcomes (2)
adimanebart SC PK parameter: Cmax
Cmax = maximum observed concentration
Measured: Up to 20 weeks
Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation
AE = adverse event ; SAE = serious adverse event
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start12 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673601
- Sponsor's protocol ID
- ARGX-119-900-XIND-1002
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07673601
- Acronym / sponsor ID
- ARGX-119-900-XIND-1002
- Conditions
- Healthy Volunteers (HV), Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jun 2026 (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 aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.
The participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.
Participants will be in the study for approximately up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Adimanebart IV | Experimental | Biological: Adimanebart IVParticipants randomized to receive adimanebart IV |
| Part 1 - Adimanebart SC (formulation A) | Experimental | Biological: Adimanebart SC - formulation AParticipants randomized to receive adimanebart SC |
| Part 2 - Adimanebart SC (formulation A) in lower body weights | Experimental | Biological: Adimanebart SC - formulation AParticipants with body weight < 60 kg will receive adimanebart SC |
| Part 2 - Adimanebart SC (formulation A) in higher body weights | Experimental | Biological: Adimanebart SC - formulation AParticipants with body weight between 100 and 130 kg will receive adimanebart SC |
| Part 3 - Adimanebart SC (formulation B) | Experimental | Biological: Adimanebart SC - formulation BParticipants randomized to receive adimanebart SC formulation B |
| Part 3 - Adimanebart SC (formulation C) | Experimental | Biological: Adimanebart SC - formulation CParticipants randomized to receive adimanebart SC formulation C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
- Has a body weight between 60 and 100 kg and a BMI between 18.5 and 30 kg/m2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight <60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg/m2, inclusive, at screening and on day -1 for part 2.
- Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
Key exclusion criteria (3 listed)
- Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and/or food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.
- Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.
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 |
|---|---|---|
| Adimanebart IVIntravenous infusion of adimanebart IV | Biological | Part 1 - Adimanebart IV |
| Adimanebart SC - formulation ASubcutaneous administration of Adminanebart SC | Biological | Part 1 - Adimanebart SC (formulation A), Part 2 - Adimanebart SC (formulation A) in higher body weights, Part 2 - Adimanebart SC (formulation A) in lower body weights |
| Adimanebart SC - formulation BSubcutaneous administration of Adminanebart SC | Biological | Part 3 - Adimanebart SC (formulation B) |
| Adimanebart SC - formulation CSubcutaneous administration of Adminanebart SC | Biological | Part 3 - Adimanebart SC (formulation C) |
Primary outcome
AUC0-inf
Time frame: Up to 20 weeks
AUC0-inf = area under the concentration-time curve from time 0 to infinity
2 secondary outcomes
adimanebart SC PK parameter: Cmax
Time frame: Up to 20 weeks
Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation
Time frame: Up to 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- 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.
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 Adimanebart IV, Adimanebart SC - formulation A and Adimanebart SC - formulation B in people with Healthy Volunteers (HV) and Healthy Volunteer, run by argenx at 1 site in Canada.
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 3 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf (time frame: Up to 20 weeks). 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 29 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.