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Recruiting NCT07673601

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

Phase I Interventional Healthy Volunteers (HV) Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adimanebart IV, Adimanebart SC - formulation A, Adimanebart SC - formulation B, Adimanebart SC - formulation C.
Who it may be relevant to
Registry conditions: Healthy Volunteers (HV), Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Biological Adimanebart IV
    Intravenous infusion of adimanebart IV
  • Biological Adimanebart SC - formulation A
    Subcutaneous administration of Adminanebart SC
  • Biological Adimanebart SC - formulation B
    Subcutaneous administration of Adminanebart SC
  • Biological Adimanebart SC - formulation C
    Subcutaneous administration of Adminanebart SC

Primary outcome measures

  • AUC0-inf [Time frame: Up to 20 weeks]
Secondary outcome measures (2)
  • adimanebart SC PK parameter: Cmax [Time frame: Up to 20 weeks]
  • Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation [Time frame: Up to 20 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Altasciences — Montreal

Identifiers

NCT: NCT07673601 · ARGX-119-900-XIND-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗