Healthy VolunteerPhase 1NCT07526116
A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults
A Phase 1 study testing REGN22044 in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans. The purpose of this study is to learn: What side effects may happen when REGN22044 is taken How much of REGN22044 is in the blood at different times Whether the body makes… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- REGN22044
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jun 2026to 8 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 1. Is judged by the investigator to be in good health as described in the protocol
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator
- Use of any prescription or non-prescription medications or nutritional supplements from approximately 14 days or 5 half-lives, whichever is longer, prior to administration of study intervention or any planned use through the end of the study, except the permitted medications as listed in the protocol
- Participants with fever (>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 8 weeks prior to the screening visit or the randomization visit, or other frequent recurrent infections deemed unacceptable as per investigator judgment
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination
- Note: Other protocol defined Inclusion/ Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants
This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans.
The purpose of this study is to learn:
- What side effects may happen when REGN22044 is taken
- How much of REGN22044 is in the blood at different times
- Whether the body makes antibodies against REGN22044 (which could make the drug less effective or could lead to side effects)
- Conditions
- Healthy Volunteer
- Being tested
- REGN22044, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN22044Drug
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) Cohorts | Experimental | Not described Receives: Drug: REGN22044; Drug: Placebo |
| Subcutaneous (SC) Cohorts | Experimental | Not described Receives: Drug: REGN22044; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 18 weeks
Severity of TEAEs
Measured: Up to 18 weeks
Secondary outcomes (1)
Concentration of REGN22044 in serum
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start5 Jun 2026
- Primary completion8 Feb 2027 (estimated)
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526116
- Sponsor's protocol ID
- R22044-HV-2533
- Other IDs
- 2025-523562-24-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 6 Apr 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07526116
- Acronym / sponsor ID
- R22044-HV-2533
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 8 Feb 2027 (estimated)
- Study completion
- 8 Feb 2027 (estimated)
- First posted
- 13 Apr 2026 (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 clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans.
The purpose of this study is to learn:
- What side effects may happen when REGN22044 is taken
- How much of REGN22044 is in the blood at different times
- Whether the body makes antibodies against REGN22044 (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) Cohorts | Experimental | Drug: REGN22044, Drug: Placebo |
| Subcutaneous (SC) Cohorts | Experimental | Drug: REGN22044, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Is judged by the investigator to be in good health as described in the protocol
Key exclusion criteria (5 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator
- Use of any prescription or non-prescription medications or nutritional supplements from approximately 14 days or 5 half-lives, whichever is longer, prior to administration of study intervention or any planned use through the end of the study, except the permitted medications as listed in the protocol
- Participants with fever (>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 8 weeks prior to the screening visit or the randomization visit, or other frequent recurrent infections deemed unacceptable as per investigator judgment
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination
- Note: Other protocol defined Inclusion/ Exclusion criteria apply.
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 |
|---|---|---|
| REGN22044Administered per the protocol | Drug | Intravenous (IV) Cohorts, Subcutaneous (SC) Cohorts |
| PlaceboAdministered per the protocol | Drug | Intravenous (IV) Cohorts, Subcutaneous (SC) Cohorts |
Primary outcome
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 18 weeks
Severity of TEAEs
Time frame: Up to 18 weeks
1 secondary outcome
Concentration of REGN22044 in serum
Time frame: Up to 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 REGN22044 in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in Belgium.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 18 weeks). The study lists 2 primary outcomes in all. 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 25 Aug 2026.