ARGX-109 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: argenx

Disqualifiers: Medical, psychiatric conditions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug called ARGX-109. Researchers aim to determine its safety and track its movement through the body by measuring blood levels over time. The study compares ARGX-109 to a placebo (a substance with no active drug) to assess any effects. Participants are healthy adults weighing between 50 and 100 kg with a BMI (body mass index) between 18.5 and 30. Generally healthy individuals fitting this profile may be suitable for the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ARGX-109 is likely to be safe for humans?

Research has shown that ARGX-109 has been tested in healthy adults to assess its safety. Early studies focus on the drug's behavior in the body. These studies are in the initial stages, with scientists primarily checking its safety for human use.

Researchers examine any side effects the drug might cause in these initial tests. The aim is to ensure ARGX-109 is well-tolerated. Reports from these studies suggest it is safe enough to continue testing, though specific details on side effects remain undisclosed. As this is an early study, scientists are still collecting safety information before advancing to more comprehensive testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ARGX-109 is unique because it introduces a novel approach by utilizing an experimental drug designed to modulate the immune system. Unlike standard treatments that might focus on symptom management, ARGX-109 targets the underlying mechanism, potentially offering a more precise intervention. Researchers are excited about its potential to provide a new pathway for treatment, which could lead to better outcomes with fewer side effects for patients.

What evidence suggests that ARGX-109 might be an effective treatment for healthy subjects?

Research shows that ARGX-109 is in the early stages of testing. In this trial, participants will receive either ARGX-109 or a placebo. The focus is on assessing its safety and observing its behavior in the body of healthy individuals. Direct evidence of its effectiveness for any specific illness is not yet available. Researchers continue to study the treatment to determine its potential future applications. While there is interest in ARGX-109, solid proof of its effectiveness for treating any particular condition is still lacking. The ongoing studies are crucial for understanding its potential uses. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to help test the safety of a new medication called ARGX-109. Participants will be involved in the study for about 20 weeks.

Inclusion Criteria

My weight is between 50 and 100 kg and my BMI is between 18.5 and 30.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ARGX-109 or placebo to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARGX-109

Trial Overview

The trial is testing ARGX-109 against a placebo, which has no active drug. It's designed to see how safe ARGX-109 is and how it moves through and acts in the body over time.

How Is the Trial Designed?

Group I: ARGX-109 Experimental Treatment 1 Intervention

Participants receiving the experimental drug

Group II: Placebo Placebo Group 1 Intervention

Participants receiving placebo

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

Published Research Related to This Trial

In a study involving 600 male Ross 308 broilers, dietary supplementation with crystalline arginine (Arg) at 100% of the recommended level significantly improved body weight gain, feed intake, and feed conversion ratio compared to lower levels (70% and 80%).

The research demonstrated that adequate Arg levels are crucial for enhancing bone mineral density and lean muscle mass in broilers, while lower Arg levels resulted in poorer growth and body composition outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-Arginine supplementation enhances growth performance, lean muscle, and bone density but not fat in broiler chickens. Castro, FLS., Su, S., Choi, H., et al.[2020]

A clinical trial involving 101 overweight or obese adults showed that daily supplementation with 30 g of L-arginine (Arg) for 90 days is safe and well-tolerated, with no adverse events reported.

Supplementation with 30 g of Arg significantly reduced systolic blood pressure and serum glucose levels in women, and decreased free fatty acid concentrations in both men and women, indicating potential health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of dietary supplementation with arginine in adult humans. McNeal, CJ., Meininger, CJ., Wilborn, CD., et al.[2018]

In a 13-week study with male and female Sprague-Dawley rats, L-arginine was found to have no significant toxicological or behavioral effects at dietary concentrations up to 5.0%, indicating it is safe for consumption at this level.

The study established a no-observed-adverse-effect level (NOAEL) for L-arginine at 5.0% (w/w), with only minor and physiologically insignificant changes in plasma glucose and red blood cell counts observed in some male rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirteen-week oral toxicity study of L-arginine in rats. Tsubuku, S., Hatayama, K., Mawatari, K., et al.[2013]

Oral l-Arginine (Arg) supplementation, up to about 20 g per day, is generally safe and well-tolerated, even in vulnerable populations like pregnant women and preterm infants.

Recent studies indicate that Arg may improve metabolic profiles, particularly in individuals with obesity, insulin resistance, and diabetes, suggesting its potential as a beneficial nutriceutical for enhancing nutrient metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Arginine in Adults. McNeal, CJ., Meininger, CJ., Reddy, D., et al.[2023]

Oral arginine (Arg) does not enhance growth hormone (GH) secretion at rest or during exercise in either young (average age 22) or older individuals (average age 68), based on a study involving 28 participants.

In fact, when Arg was taken during exercise, it appeared to blunt GH release in young individuals compared to exercise alone, suggesting that Arg may not be beneficial for stimulating GH secretion during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral arginine does not stimulate basal or augment exercise-induced GH secretion in either young or old adults. Marcell, TJ., Taaffe, DR., Hawkins, SA., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06799416

A Study to Assess the Safety of ARGX-109 in Healthy ...

Study Overview​​ 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 ...

2.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-2025-bb5c2

ARGX-109 for Healthy Subjects · Info for Participants

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 ...

3.

reports.argenx.com

reports.argenx.com/2024/argenx-group/2024-in-brief.html

2024 In Brief - Annual Report 2024 - Argenx

Phase 1 results expected for ARGX-109 in second half of 2025 and for ARGX-213 and ARGX-121 in first half of 2026.

4.

tipranks.com

tipranks.com/news/company-announcements/argenx-completes-phase-1-study-on-argx-109-key-insights-for-investors

Argenx Completes Phase 1 Study on ARGX-109

The study aimed to assess the safety and movement of ARGX-109 in the body of healthy volunteers, providing critical insights into its potential ...

5.

biospace.com

biospace.com/press-releases/argenx-reports-half-year-2025-financial-results-and-provides-second-quarter-business-update

argenx Reports Half Year 2025 Financial Results and ...

Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-assess-the-safety-of-argx-109-in-healthy-volunteers

A Study to Assess the Safety of ARGX-109 in Healthy Volunteers

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 ...

7.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/ARGX/pressreleases/34922076/argenx-completes-phase-1-study-on-argx-109-key-insights-for-investors/

Argenx Completes Phase 1 Study on ARGX-109

The study aimed to assess the safety and movement of ARGX-109 in the body of healthy volunteers, providing critical insights into its potential ...

8.

argenx.com

argenx.com/content/dam/argenx-corp/media-documents/ARGX_2024_JPM_Corporate_Presentation.pdf

The Next Chapter

ARGX-109. (Anti-IL-6). ARGX-213. (Anti-FcRn). ARGX-220. ARGX-121 ... Safety and tolerability data from extensive Phase 1 study support advancement ...