NCT06968338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2025

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

May 5, 2025

Last Update Submit

April 22, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation

    Up to 17 weeks

Secondary Outcomes (3)

  • 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

    Up to 17 weeks

Study Arms (2)

ARGX-213

EXPERIMENTAL

Participants receiving the experimental drug

Biological: ARGX-213

Placebo

PLACEBO COMPARATOR

Participants receiving placebo

Other: Placebo

Interventions

ARGX-213BIOLOGICAL

Intravenous or subcutaneous administrations of ARGX-213

ARGX-213
PlaceboOTHER

Intravenous or subcutaneous administrations of placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences

Montreal, QC H3P 3P1, Canada

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

April 11, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)