Healthy VolunteersPhase 1NCT04073589
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
A Phase 1 study testing ARGX-113 with rHuPH20 in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.
Trial summary
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ARGX-113 with rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jul 2019to 26 Sep 2019
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male, between 18 to 70 years of age
- Subject is healthy
- Subject has a body mass index (BMI) between 18 kg/m2 to 30 kg/m2
- Subject is willing and able to understand the purpose and risks of the trial and provide signed and dated informed consent,
- Others as defined in the protocol
Who cannot join
- Previous participation in clinical trials with efgartigimod and/or any products with rHuPH20.
- Known hypersensitivity to IMP ingredients or history of a severe allergic or anaphylactic reaction to any drug as determined by the investigator.
- Known seropositivity or positive test at screening for an active viral infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV).
- Known clinically relevant immunological disorders.
- Known history or any symptom of clinically significant illness in the 6 months before IMP administration.
- Others as defined in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-group Trial to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Different Single Subcutaneous Dose Levels of Efgartigimod Co-administered With rHuPH20 in Healthy Adult Male Subjects
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20 by the subcutaneous (SC) route of administration in healthy adult male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- ARGX-113 with rHuPH20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-113 with rHuPH20Biological
Also called efgartigimod with rHuPH20
subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single SC injection of Dose A Receives: Biological: ARGX-113 with rHuPH20 |
| Treatment B | Experimental | Single SC injection of Dose B Receives: Biological: ARGX-113 with rHuPH20 |
| Treatment C | Experimental | Single SC injection of Dose C Receives: Biological: ARGX-113 with rHuPH20 |
| Treatment D | Experimental | Single SC injection of Dose D Receives: Biological: ARGX-113 with rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG levels of four different subcutaneous dose levels
Measured: Up to 11 weeks, from study start until the end of the study
Secondary outcomes (6)
Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Measured: Up to 11 weeks, from study start until the end of the study
Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Measured: Up to 11 weeks, from study start until the end of the study
Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Measured: Up to 11 weeks, from study start until the end of the study
Number of (serious) adverse events
Measured: Up to 11 weeks, from study start until the end of the study
Level of anti-drug antibodies
Measured: Up to 11 weeks, from study start until the end of the study
Time required to administer the different doses
Measured: Up to 11 weeks, from study start until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start17 Jul 2019
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
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
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Guglietta, MD, Study director, argenx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073589
- Sponsor's protocol ID
- ARGX-113-1901
- Other IDs
- 2019-002102-40, 2019
- Status last verified
- Dec 2019
- First submitted
- 16 Aug 2019
- Last updated
- 30 Dec 2019
- 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 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-group Trial to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Different Single Subcutaneous Dose Levels of Efgartigimod Co-administered With rHuPH20 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT04073589
- Acronym / sponsor ID
- ARGX-113-1901
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 29 Aug 2019 (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.
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20 by the subcutaneous (SC) route of administration in healthy adult male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Biological: ARGX-113 with rHuPH20Single SC injection of Dose A |
| Treatment B | Experimental | Biological: ARGX-113 with rHuPH20Single SC injection of Dose B |
| Treatment C | Experimental | Biological: ARGX-113 with rHuPH20Single SC injection of Dose C |
| Treatment D | Experimental | Biological: ARGX-113 with rHuPH20Single SC injection of Dose D |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male, between 18 to 70 years of age
- Subject is healthy
- Subject has a body mass index (BMI) between 18 kg/m2 to 30 kg/m2
- Subject is willing and able to understand the purpose and risks of the trial and provide signed and dated informed consent,
- Others as defined in the protocol
Key exclusion criteria (6 listed)
- Previous participation in clinical trials with efgartigimod and/or any products with rHuPH20.
- Known hypersensitivity to IMP ingredients or history of a severe allergic or anaphylactic reaction to any drug as determined by the investigator.
- Known seropositivity or positive test at screening for an active viral infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV).
- Known clinically relevant immunological disorders.
- Known history or any symptom of clinically significant illness in the 6 months before IMP administration.
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-113 with rHuPH20Also: efgartigimod with rHuPH20subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20) | Biological | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
IgG levels of four different subcutaneous dose levels
Time frame: Up to 11 weeks, from study start until the end of the study
6 secondary outcomes
Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Time frame: Up to 11 weeks, from study start until the end of the study
Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Time frame: Up to 11 weeks, from study start until the end of the study
Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
Time frame: Up to 11 weeks, from study start until the end of the study
Number of (serious) adverse events
Time frame: Up to 11 weeks, from study start until the end of the study
Level of anti-drug antibodies
Time frame: Up to 11 weeks, from study start until the end of the study
Time required to administer the different doses
Time frame: Up to 11 weeks, from study start until the end of the study
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 30 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Guglietta, MD study director
argenx
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-113 with rHuPH20 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 5 inclusion and 6 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 30 Dec 2019. 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. 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?
IgG levels of four different subcutaneous dose levels (time frame: Up to 11 weeks, from study start until the end of the study). 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 30 Dec 2019.