NCT06799416

Brief Summary

This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_1

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

January 14, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

January 23, 2025

Last Update Submit

September 17, 2025

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Incidence of AEs, SAEs and AEs leading to discontinuation

    AE: adverse event, SAE: serious adverse event

    up to 16 weeks

Secondary Outcomes (3)

  • Cmax

    up to 16 weeks

  • Total IL-6 serum concentrations

    up to 16 weeks

  • Incidence of ADA against ARGX-109 in serum

    up to 16 weeks

Study Arms (2)

ARGX-109

EXPERIMENTAL

Participants receiving the experimental drug

Biological: ARGX-109

Placebo

PLACEBO COMPARATOR

Participants receiving placebo

Other: Placebo

Interventions

ARGX-109BIOLOGICAL

administrations of ARGX-109

ARGX-109
PlaceboOTHER

administrations of placebo comparator

Placebo

Eligibility Criteria

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

You may qualify if:

  • is aged 18 to 65 years, inclusive, when signing the ICF
  • has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 kg/m2, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences - Montreal - Phase I unit

Mount Royal, Quebec, H3P 3P1, Canada

Location

Study Design

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

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 29, 2025

Study Start

January 14, 2025

Primary Completion

August 8, 2025

Study Completion

August 8, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)