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

NCT07673601 | Recruiting Phase 1

• 1 other identifier: ARGX-119-900-XIND-1002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AUC0-inf

  AUC0-inf = area under the concentration-time curve from time 0 to infinity

  Up to 20 weeks

Secondary Outcomes (2)

• adimanebart SC PK parameter: Cmax

  Up to 20 weeks

• Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation

  Up to 20 weeks

Study Arms (6)

Part 1 - Adimanebart IV

EXPERIMENTAL

Participants randomized to receive adimanebart IV

Biological: Adimanebart IV

Part 1 - Adimanebart SC (formulation A)

EXPERIMENTAL

Participants randomized to receive adimanebart SC

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

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

Biological: Adimanebart SC - formulation A

Part 3 - Adimanebart SC (formulation B)

EXPERIMENTAL

Participants randomized to receive adimanebart SC formulation B

Biological: Adimanebart SC - formulation B

Part 3 - Adimanebart SC (formulation C)

EXPERIMENTAL

Participants randomized to receive adimanebart SC formulation C

Biological: Adimanebart SC - formulation C

Interventions

Adimanebart IV BIOLOGICAL

Intravenous infusion of adimanebart IV

Part 1 - Adimanebart IV

Adimanebart SC - formulation A BIOLOGICAL

Subcutaneous administration of Adminanebart SC

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 B BIOLOGICAL

Subcutaneous administration of Adminanebart SC

Part 3 - Adimanebart SC (formulation B)

Adimanebart SC - formulation C BIOLOGICAL

Subcutaneous administration of Adminanebart SC

Part 3 - Adimanebart SC (formulation C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

Altasciences

Montreal, H3P 3P1, Canada

RECRUITING

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)