A Study to Assess the Safety of ARGX-213 in Healthy Volun... | NCT06968338

Studies
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers

NCT06968338

Sponsor

argenx

Status

Completed

Last Update Posted

Apr 23, 2026Actual

Enrollment

88Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

ARGX-213
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

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2025Actual

Primary Completion Date

Mar 20, 2026Actual

Completion Date

Mar 20, 2026Actual

First Submitted Date

May 5, 2025

First Submission Date that Met QC Criteria

May 5, 2025

First Posted Date

May 13, 2025Actual

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

Apr 22, 2026

Last Update Posted Date

Apr 23, 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-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body. The participants will remain in the study for approximately up to 21 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

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARGX-213	Experimental	Participants receiving the experimental drug	Biological: ARGX-213
Placebo	Placebo Comparator	Participants receiving placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARGX-213	Biological	Intravenous or subcutaneous administrations of ARGX-213	ARGX-213

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation		Up to 17 weeks

Secondary Outcomes

Measure	Description	Time Frame
ARGX-213 serum concentrations		Up to 17 weeks
Percent change from baseline in total IgG concentrations in serum		Up to 17 weeks
Incidence of antidrug antibodies against ARGX-213 in serum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is at least the local legal age of consent for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF
Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male
Has a body weight between 50 and 100 kg and a BMI between 18 and 30.5 kg/m^2, inclusive

Exclusion Criteria:

Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
Has a clinically meaningful abnormality detected on ECG recording regarding either rhythm or conduction

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altasciences		Montreal		QC 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