How Adimanebart Moves Through the Body in Healthy Adults
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
Run by argenx · NCT07673601 · Data updated 2026-11-12
This study tests how much adimanebart enters the blood and how it behaves in healthy adults after IV and SC dosing.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | argenx Industry-sponsored |
| Locations | 1 site (Montreal) |
| Status | Recruiting |
| Started | June 12, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT07673601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18 to 65 with body weight 60–100 kg (BMI 18.5–30) for parts 1 and 3, or 60–130 kg with BMI 18.5–38 for part 2, who can abstain from most medications for at least two weeks prior to dosing.
✕Probably not a fit
Participants who do not meet the weight/BMI criteria or who have significant medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study investigates the absolute bioavailability and pharmacokinetics of adimanebart in healthy volunteers. Participants are divided into three parts: IV administration to assess bioavailability, SC dosing to explore the effect of body weight on blood levels, and formulation adjustments to optimize delivery. The study runs for up to 24 weeks, with safety monitoring throughout. Data will help determine how adimanebart moves through the body and inform future dosing considerations.
Why it matters
Potential benefit: If successful, the study could inform dosing strategies and formulation choices for adimanebart in broader use.
How similar studies have gone: Prior Phase 1 pharmacokinetic studies have used similar designs to characterize bioavailability and SC formulation effects for monoclonal antibody therapies, supporting feasibility.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Altasciences
Montreal, Canada Recruiting
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.