Recruiting
Phase 1

Adimanebart

Sponsor:

argenx

Code:

NCT07673601

Conditions

Healthy Volunteers (HV)

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Adimanebart IV

Adimanebart SC - formulation A

Adimanebart SC - formulation B

Adimanebart SC - formulation C

Study Details

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.

Conditions

Healthy Volunteers (HV)

Healthy Volunteer

Study ID

NCT07673601

Start date

Jun 12, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 - Adimanebart IV

Participants randomized to receive adimanebart IV

experimental: Part 1 - Adimanebart SC (formulation A)

Participants randomized to receive adimanebart SC

experimental: Part 2 - Adimanebart SC (formulation A) in lower body weights

Participants with body weight < 60 kg will receive adimanebart SC

experimental: Part 2 - Adimanebart SC (formulation A) in higher body weights

Participants with body weight between 100 and 130 kg will receive adimanebart SC

experimental: Part 3 - Adimanebart SC (formulation B)

Participants randomized to receive adimanebart SC formulation B

experimental: Part 3 - Adimanebart SC (formulation C)

Participants randomized to receive adimanebart SC formulation C

Interventions

Adimanebart IV

Intravenous infusion of adimanebart IV

Adimanebart SC - formulation A

Subcutaneous administration of Adminanebart SC

Adimanebart SC - formulation B

Subcutaneous administration of Adminanebart SC

Adimanebart SC - formulation C

Subcutaneous administration of Adminanebart SC

Primary outcome measure

  • AUC0-inf [ Time Frame: Up to 20 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Altasciences

Recruiting

Montreal, Canada, H3P 3P1

Contacts

Gaetano Morelli, MD

857-350-4834clinicaltrials@argenx.com

More Information

Sponsor

argenx

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by argenx on 2026-06-29.