Healthy VolunteersPhase 1NCT03115996
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers
A Phase 1 study testing REGN3918 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
Trial summary
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN3918
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2017to 31 Aug 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject must meet the follow criteria to be eligible for inclusion in the study:
- Males and females from 18 to 50 years of age.
- Subject is judged to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
- The subject has a body mass index less than 30 kg/m2
- Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides.
Who cannot join
- A subject who meets any of the following criteria will be excluded from the study:
- Any clinically significant physical examination abnormalities observed during the screening visit.
- Hospitalization for any reason within 30 days of the screening visit
- Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals.
- Subject has a history of meningococcal infection.
- Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening.
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- Subject has had a splenectomy.
- Known allergy to penicillin class antibiotics
- Known or suspected complement deficiency, or abnormal complement C3, C4 or CH50 during screening.
- Recent (within the previous 2 months) bacterial, protozoal, viral or parasite infection requiring systemic treatment.
- History of tuberculosis or systemic fungal diseases
- HIV infection or HIV seropositivity at the screening visit
- Positive HBsAg, HBcAb, or hepatitis C antibody at the screening visit
- History of malignancy (except non-melanoma skin cancer or cervical in-situ)
- Pregnant or breastfeeding women
- Women of childbearing potential and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit (CRU) Ltd.
Leeds, LS2 9LH
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
Read the detailed description
Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.
- Conditions
- Healthy Volunteers
- Being tested
- REGN3918, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN3918Drug
Intravenous (IV) or Subcutaneous (SC)
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| REGN3918 (Cohorts 1-4 & 6a) | Experimental | Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918 Receives: Drug: REGN3918 |
| Placebo (Cohorts 1-4 & 6a) | Experimental | Cohorts 1-4 and 6a will receive placebo Receives: Drug: Placebo |
| REGN3918 (Cohort 5 & 6b) | Experimental | Cohort 5 and 6b will receive multiple doses of REGN3918 Receives: Drug: REGN3918 |
| Placebo (Cohort 5 & 6b) | Experimental | Cohort 5 and 6b will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Measured: Up to 20 weeks
Severity of TEAEs
Measured: Up to 20 weeks
Secondary outcomes (5)
Pharmacokinetic profile of REGN3918; single dose IV and SC
Assessed via serum concentrations of REGN3918 over time; Area under the Curve (AUC)
Measured: Up to 20 weeks
Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses
Assessed via serum concentrations of REGN3918 over time; peak concentration Cmax
Measured: Up to 20 weeks
Pharmacodynamics profile of REGN3918
Assessed by CH50 assay over time
Measured: Up to 20 weeks
Pharmacokinetic exploratory analysis
Peak concentration Cmax
Measured: Up to 20 weeks
Immunogenicity of REGN3918
Assessed by measurement of anti-drug antibodies (ADA)
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start10 May 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
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
- NCT03115996
- Sponsor's protocol ID
- R3918-HV-1659
- Other IDs
- 2016-004208-70, 2016
- Status last verified
- Sep 2018
- First submitted
- 5 Apr 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7.
PubMed 36494054
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03115996
- Acronym / sponsor ID
- R3918-HV-1659
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 14 Apr 2017 (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.
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
Detailed description
Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| REGN3918 (Cohorts 1-4 & 6a) | Experimental | Drug: REGN3918Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918 |
| Placebo (Cohorts 1-4 & 6a) | Experimental | Drug: PlaceboCohorts 1-4 and 6a will receive placebo |
| REGN3918 (Cohort 5 & 6b) | Experimental | Drug: REGN3918Cohort 5 and 6b will receive multiple doses of REGN3918 |
| Placebo (Cohort 5 & 6b) | Experimental | Drug: PlaceboCohort 5 and 6b will receive placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females from 18 to 50 years of age.
- Subject is judged to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
- The subject has a body mass index less than 30 kg/m2
- Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides.
Key exclusion criteria (17 listed)
- Any clinically significant physical examination abnormalities observed during the screening visit.
- Hospitalization for any reason within 30 days of the screening visit
- Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals.
- Subject has a history of meningococcal infection.
- Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening.
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 |
|---|---|---|
| REGN3918Intravenous (IV) or Subcutaneous (SC) | Drug | REGN3918 (Cohort 5 & 6b), REGN3918 (Cohorts 1-4 & 6a) |
| PlaceboMatching Placebo | Drug | Placebo (Cohort 5 & 6b), Placebo (Cohorts 1-4 & 6a) |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 20 weeks
Severity of TEAEs
Time frame: Up to 20 weeks
5 secondary outcomes
Pharmacokinetic profile of REGN3918; single dose IV and SC
Time frame: Up to 20 weeks
Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses
Time frame: Up to 20 weeks
Pharmacodynamics profile of REGN3918
Time frame: Up to 20 weeks
Pharmacokinetic exploratory analysis
Time frame: Up to 20 weeks
Immunogenicity of REGN3918
Time frame: Up to 20 weeks
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 26 Sep 2018.
- Derived from this study: PubMed 36494054Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7.
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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.
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 REGN3918 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
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 17 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 26 Sep 2018. 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 United Kingdom. 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?
Incidence of treatment emergent adverse events (TEAEs) (time frame: Up to 20 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?
On the ClinicalTrials.gov record for NCT03115996, 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 26 Sep 2018.