Healthy VolunteersPhase 1NCT02958436
A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
A Phase 1 study testing REGN3500 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females 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?
- REGN3500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2016to 3 Oct 2017
- 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
- Body Mass Index</= 33 kg/m2
- In good health based on medical history, physical examination, vital signs, and laboratory testing
- Normal electrocardiogram (ECG) and blood pressure
- Able to comply with clinic visits and study-related procedures
- Able to sign an informed consent
Who cannot join
- Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
- Current smoker or recent history (within 3 months)
- History of tuberculosis, HIV, or hepatic disease
- Known sensitivity to doxycycline or other ingredients of study drug
- History of multiple/severe allergies
- Pregnant or breastfeeding women, or not currently using adequate contraception
- Participation in another investigational drug study within 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females
- Conditions
- Healthy Volunteers
- Being tested
- REGN3500, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, REGN3500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN3500Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose regimen 1 of REGN3500 (IV) versus placebo Receives: Drug: REGN3500; Drug: Placebo |
| Cohort 2 | Experimental | Dose regimen 2 of REGN3500 (IV) versus placebo Receives: Drug: REGN3500; Drug: Placebo |
| Cohort 3 | Experimental | Dose regimen 3 of REGN3500 (IV) versus placebo Receives: Drug: REGN3500; Drug: Placebo |
| Cohort 4 | Experimental | Dose regimen 4 of REGN3500 (SC) versus placebo Receives: Drug: REGN3500; Drug: Placebo |
| Cohort 5 | Experimental | Dose regimen 5 of REGN3500 (IV) versus placebo Receives: Drug: REGN3500; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
Measured: Up to 293 days after dosing
Secondary outcomes (3)
Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500
Measured: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500
Measured: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500
Measured: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startAug 2016
- Primary completion18 Jun 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958436
- Sponsor's protocol ID
- R3500-HV-1551
- Other IDs
- 2016-002012-41, 2016
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.
PubMed 34523807
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. 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 of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02958436
- Acronym / sponsor ID
- R3500-HV-1551
- Conditions
- Healthy Volunteers
- Keywords
- Safety, Tolerability, Pharmacokinetics, REGN3500
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Aug 2016 (actual)
- Primary completion
- 18 Jun 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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 primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN3500, Drug: PlaceboDose regimen 1 of REGN3500 (IV) versus placebo |
| Cohort 2 | Experimental | Drug: REGN3500, Drug: PlaceboDose regimen 2 of REGN3500 (IV) versus placebo |
| Cohort 3 | Experimental | Drug: REGN3500, Drug: PlaceboDose regimen 3 of REGN3500 (IV) versus placebo |
| Cohort 4 | Experimental | Drug: REGN3500, Drug: PlaceboDose regimen 4 of REGN3500 (SC) versus placebo |
| Cohort 5 | Experimental | Drug: REGN3500, Drug: PlaceboDose regimen 5 of REGN3500 (IV) versus placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index</= 33 kg/m2
- In good health based on medical history, physical examination, vital signs, and laboratory testing
- Normal electrocardiogram (ECG) and blood pressure
- Able to comply with clinic visits and study-related procedures
- Able to sign an informed consent
Key exclusion criteria (7 listed)
- Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
- Current smoker or recent history (within 3 months)
- History of tuberculosis, HIV, or hepatic disease
- Known sensitivity to doxycycline or other ingredients of study drug
- History of multiple/severe allergies
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 |
|---|---|---|
| REGN3500 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
Time frame: Up to 293 days after dosing
3 secondary outcomes
Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500
Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500
Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500
Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
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 8 Nov 2017.
- Derived from this study: PubMed 34523807Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.
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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. This study is not recruiting at the moment.
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 REGN3500 in people with Healthy Volunteers, 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 5 inclusion and 7 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 8 Nov 2017. 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?
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?
The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500 (time frame: Up to 293 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958436, which also lists 1 linked publication.
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 8 Nov 2017.