A Study to Assess the Safety of ARGX-124 in Healthy Volun... | NCT07377396

Studies
A Study to Assess the Safety of ARGX-124 in Healthy Volunteers

NCT07377396

Sponsor

argenx

Status

Recruiting

Last Update Posted

Mar 6, 2026Actual

Enrollment

104Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

ARGX-124
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2026Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 22, 2026

First Submission Date that Met QC Criteria

Jan 22, 2026

First Posted Date

Jan 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2026

Last Update Posted Date

Mar 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it. Participants will remain in the study for up to approximately 23 weeks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARGX-124	Experimental	Participants receiving the experimental drug	Biological: ARGX-124
Placebo	Placebo Comparator	Participants receiving placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARGX-124	Biological	Administrations of ARGX-124	ARGX-124
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation	AE : adverse event ; SAE : serious adverse event.	Up to 23 weeks

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed serum concentration (Cmax)		Up to 23 weeks
Percent change from baseline in total IgG levels in serum over time	IgG : immunoglobulin G	Up to 23 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.
Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, inclusive.

Exclusion Criteria:

Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
Has IgG levels <6.0 g/L at screening.
Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.
Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sabine Coppieters, MD	Contact	857-350-4834		clinicaltrials@argenx.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altasciences	Recruiting	Montreal		H3P 3P1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided