Healthy VolunteersPhase 1NCT05670704
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
A Phase 1 study testing ARGX-119 in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.
Trial summary
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy participants. The study IMPs are ARGX-119 or placebo for IV or SC administration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ARGX-119
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Feb 2023to 8 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has reached the age of consent at the time of signing the informed consent form and ≤65 years of age
- Is capable of providing signed informed consent and understands and is capable of complying with protocol requirements
- Is a healthy participant, defined as having no clinically meaningful abnormalities identified in any of the following assessments before the first IMP administration on day 1: medical history, physical examination, standard 12-lead ECG, vital sign measurements, and clinical laboratory tests
- Is either male or female of nonchildbearing potential.
- Has negative serum pregnancy tests at both screening and on day -1 (female participants)
- Has a BMI within the range of 18 to 30 kg/m2 and a body weight within the range of 50 to 100 kg (inclusive) before first IMP administration
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- Agree to use contraceptive measures consistent with local regulations
- Agrees to discontinue and refrain from using all medications, including nonprescription and prescription medications, for ≥2 weeks before their first IMP administration through the study. The occasional use of paracetamol is allowed upon approval by the investigator.
- Is a nonsmoker (defined as an individual who has abstained from smoking for ≥3 months before screening) and does not use nicotine-containing products
- Has a negative drug and alcohol test for amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants, and alcohol at screening and on day -1
- Has a body temperature of 35.5 °C to 37.6 °C at screening and before their first IMP administration on day 1
Who cannot join
- Has a known hypersensitivity to any of the components of the IMP, or has a history of a significant allergic reaction to any drug that is considered exclusionary by the investigator
- Has been given an investigational product within 3 months or 5 half-lives (whichever is longer) before their first IMP administration
- Has a positive serum test at screening for an active infection with any of the following conditions: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test, HCV based on HCV antibody assay unless a negative RNA test is available, HIV based on test results
- Has a positive COVID-19 test result on day -1, if performed.
- Has a history of any medical or psychiatric condition that, in the opinion of the investigator, is clinically meaningful, may confound the result of the study, or may pose additional risks to the participant while taking part in the study
- Has clinically relevant abnormalities detected on an ECG that are related to either rhythm or conduction
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- Has a clinically meaningful abnormality in any screening test or vital sign measurement before their first IMP administration
- Has had an event causing significant blood loss (including blood donation >500 mL) or a transfusion of any blood product ≤12 weeks before their first IMP administration
- Has a history of any of the following: Consuming >21 units of alcoholic beverages per week ≤2 years before screening; Alcoholism or drug, chemical, or substance abuse ≤2 years before screening; Consuming a large quantity (>6 cups a day) of coffee, tea, or equivalent during the 4 week screening period
- Has any condition that impairs phlebotomy, including (but not limited to) coagulation disorders (hemophilia A, hemophilia B, Von Willebrand disease), clotting factor deficiencies, or any other condition that would increase the risk of hematoma formation
- Is an investigator, subinvestigator, research assistant, pharmacist, study coordinator, or other staff or relative of study personnel directly involved with the conduct of the study
- Has any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy participants. The study IMPs are ARGX-119 or placebo for IV or SC administration.
This study will include 2 parts:
- In part A, ARGX-119 IV (or placebo IV) will be administered to 9 cohorts as single doses , while ARGX-119 SC (or placebo SC) will be administered to a 10th cohort.
- In part B, 4 once-weekly IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.
- Conditions
- Healthy Volunteers
- Being tested
- ARGX-119, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-119Biological
Patients receiving ARGX-119 IV or SC
PlaceboOther
Patients receiving Placebo IV or SC
| Study group | Role | What they receive |
|---|---|---|
| ARGX-119 | Experimental | Patients receiving ARGX-119 IV or SC Receives: Biological: ARGX-119 |
| Placebo | Placebo comparator | Patients receiving Placebo IV or SC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events (TEAEs)
Measured: up to 157 days for part A, 117 days for part B
Secondary outcomes (4)
Pharmacokinetic parameters of ARGX-119: Area Under The Curve (AUC)
Measured: up to 157 days for part A, 117 days for part B
Pharmacokinetic parameters of ARGX-119: Maximum serum concentrations (Cmax)
Measured: up to 157 days for part A, 117 days for part B
Pharmacokinetic parameters of ARGX-119: Time to reach maximum serum concentrations (Tmax)
Measured: up to 157 days for part A, 117 days for part B
Incidence of antidrug antibodies against ARGX-119
Measured: up to 157 days for part A, 117 days for part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start21 Feb 2023
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670704
- Sponsor's protocol ID
- ARGX-119-2201
- Other IDs
- 2022-002529-90
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05670704
- Acronym / sponsor ID
- ARGX-119-2201
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy participants. The study IMPs are ARGX-119 or placebo for IV or SC administration.
This study will include 2 parts:
- In part A, ARGX-119 IV (or placebo IV) will be administered to 9 cohorts as single doses , while ARGX-119 SC (or placebo SC) will be administered to a 10th cohort.
- In part B, 4 once-weekly IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARGX-119 | Experimental | Biological: ARGX-119Patients receiving ARGX-119 IV or SC |
| Placebo | Placebo comparator | Other: PlaceboPatients receiving Placebo IV or SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has reached the age of consent at the time of signing the informed consent form and ≤65 years of age
- Is capable of providing signed informed consent and understands and is capable of complying with protocol requirements
- Is a healthy participant, defined as having no clinically meaningful abnormalities identified in any of the following assessments before the first IMP administration on day 1: medical history, physical examination, standard 12-lead ECG, vital sign measurements, and clinical laboratory tests
- Is either male or female of nonchildbearing potential.
- Has negative serum pregnancy tests at both screening and on day -1 (female participants)
Key exclusion criteria (12 listed)
- Has a known hypersensitivity to any of the components of the IMP, or has a history of a significant allergic reaction to any drug that is considered exclusionary by the investigator
- Has been given an investigational product within 3 months or 5 half-lives (whichever is longer) before their first IMP administration
- Has a positive serum test at screening for an active infection with any of the following conditions: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test, HCV based on HCV antibody assay unless a negative RNA test is available, HIV based on test results
- Has a positive COVID-19 test result on day -1, if performed.
- Has a history of any medical or psychiatric condition that, in the opinion of the investigator, is clinically meaningful, may confound the result of the study, or may pose additional risks to the participant while taking part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGX-119Patients receiving ARGX-119 IV or SC | Biological | ARGX-119 |
| PlaceboPatients receiving Placebo IV or SC | Other | Placebo |
Primary outcome
Number of treatment-emergent adverse events (TEAEs)
Time frame: up to 157 days for part A, 117 days for part B
4 secondary outcomes
Pharmacokinetic parameters of ARGX-119: Area Under The Curve (AUC)
Time frame: up to 157 days for part A, 117 days for part B
Pharmacokinetic parameters of ARGX-119: Maximum serum concentrations (Cmax)
Time frame: up to 157 days for part A, 117 days for part B
Pharmacokinetic parameters of ARGX-119: Time to reach maximum serum concentrations (Tmax)
Time frame: up to 157 days for part A, 117 days for part B
Incidence of antidrug antibodies against ARGX-119
Time frame: up to 157 days for part A, 117 days for part B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARGX-119 in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events (TEAEs) (time frame: up to 157 days for part A, 117 days for part B). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.