NCT07673601 A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants
| NCT ID | NCT07673601 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | argenx |
| Condition | Healthy Volunteers (HV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2026-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07673601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteers (HV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07673601 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07673601 currently recruiting?
Yes, NCT07673601 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT07673601 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07673601 clinical trial?
NCT07673601 is sponsored by argenx. The trial plans to enroll 52 participants.