A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer; Healthy Volunteers (HV)
• Intervention / Treatment: Biological: Adimanebart IV; Biological: Adimanebart SC - formulation A; Biological: Adimanebart SC - formulation B; Biological: Adimanebart SC - formulation C

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sabine Coppieters, MD; Phone Number: 857-350-4834; Email: clinicaltrials@argenx.com

Study Locations

• Canada
  • Montreal, Canada, H3P 3P1
    • Recruiting
    • Altasciences
    • Contact: Gaetano Morelli, MD; Phone Number: 857-350-4834; Email: clinicaltrials@argenx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 - Adimanebart IV; Participants randomized to receive adimanebart IV	Biological: Adimanebart IV; Intravenous infusion of adimanebart IV
Experimental: Part 1 - Adimanebart SC (formulation A); Participants randomized to receive adimanebart SC	Biological: Adimanebart SC - formulation A; Subcutaneous administration of Adminanebart SC
Experimental: Part 2 - Adimanebart SC (formulation A) in lower body weights; Participants with body weight < 60 kg will receive adimanebart SC	Biological: Adimanebart SC - formulation A; Subcutaneous administration of Adminanebart 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	Biological: Adimanebart SC - formulation A; Subcutaneous administration of Adminanebart SC
Experimental: Part 3 - Adimanebart SC (formulation B); Participants randomized to receive adimanebart SC formulation B	Biological: Adimanebart SC - formulation B; Subcutaneous administration of Adminanebart SC
Experimental: Part 3 - Adimanebart SC (formulation C); Participants randomized to receive adimanebart SC formulation C	Biological: Adimanebart SC - formulation C; Subcutaneous administration of Adminanebart SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf	AUC0-inf = area under the concentration-time curve from time 0 to infinity	Up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adimanebart SC PK parameter: Cmax	Cmax = maximum observed concentration	Up to 20 weeks
Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation	AE = adverse event ; SAE = serious adverse event	Up to 20 weeks

Collaborators and Investigators

• Sponsor: argenx

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ARGX-119-900-XIND-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No