Healthy VolunteerPhase 1NCT04616105
Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers
A Phase 1 study testing REGN6490 in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of 3 single ascending subcutaneous (SC) doses and 1 single intravenous (IV) dose of REGN6490 in healthy first-generation Japanese adult participants The secondary objectives of the study are: To characterize the pharmacokinetic (PK) profile… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- REGN6490
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 28 May 2021
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a male or female first-generation Japanese participant 20 to 60 years of age (inclusive) at screening visit. First-generation Japanese subject must: (a) Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan, (b) Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet, (c) Have lived <10 years outside of Japan
- Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug
- Is in good health based on laboratory safety testing obtained at the screening visit
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study participant
Who cannot join
- History of clinically significant cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
- Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation
- Hospitalization (>24 hours) for any reason within 30 days of the screening visit
- Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit
- Note: Other protocol defined Inclusion/Exclusion criteria apply
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 REGN6490 in Healthy Japanese Volunteers
The primary objective of the study is to evaluate the safety and tolerability of 3 single ascending subcutaneous (SC) doses and 1 single intravenous (IV) dose of REGN6490 in healthy first-generation Japanese adult participants
The secondary objectives of the study are:
- To characterize the pharmacokinetic (PK) profile of single SC and IV doses of REGN6490 in healthy first-generation Japanese adult participants
- Assess immunogenicity of REGN6490 in healthy first-generation Japanese adult participants dosed with a single IV or SC dose of REGN6490
- Conditions
- Healthy Volunteer
- Being tested
- REGN6490, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN6490Drug
Single dose of REGN6490
PlaceboDrug
Placebo matching single dose of REGN6490
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single ascending subcutaneous (SC) dose 1 of REGN6490 or matching placebo Receives: Drug: REGN6490; Drug: Placebo |
| Cohort 2 | Experimental | Single ascending subcutaneous (SC) dose 2 of REGN6490 or matching placebo Receives: Drug: REGN6490; Drug: Placebo |
| Cohort 3 | Experimental | Single ascending subcutaneous (SC) dose 3 of REGN6490 or matching placebo Receives: Drug: REGN6490; Drug: Placebo |
| Cohort 4 | Experimental | Single ascending intravenous (IV) dose 4 of REGN6490 or matching placebo Receives: Drug: REGN6490; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)
Measured: Up to Week 16
Secondary outcomes (2)
Serum Concentration of REGN6490 over time
Measured: Up to Week 16
Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start18 Nov 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Why it stopped: Sponsor decision
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
- 19 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
- NCT04616105
- Sponsor's protocol ID
- R6490-HV-1993
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2020
- Last updated
- 11 Nov 2021
- 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 11 Nov 2021. 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 REGN6490 in Healthy Japanese Volunteers
- ClinicalTrials.gov ID
- NCT04616105
- Acronym / sponsor ID
- R6490-HV-1993
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 4 Nov 2020 (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 primary objective of the study is to evaluate the safety and tolerability of 3 single ascending subcutaneous (SC) doses and 1 single intravenous (IV) dose of REGN6490 in healthy first-generation Japanese adult participants
The secondary objectives of the study are:
- To characterize the pharmacokinetic (PK) profile of single SC and IV doses of REGN6490 in healthy first-generation Japanese adult participants
- Assess immunogenicity of REGN6490 in healthy first-generation Japanese adult participants dosed with a single IV or SC dose of REGN6490
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN6490, Drug: PlaceboSingle ascending subcutaneous (SC) dose 1 of REGN6490 or matching placebo |
| Cohort 2 | Experimental | Drug: REGN6490, Drug: PlaceboSingle ascending subcutaneous (SC) dose 2 of REGN6490 or matching placebo |
| Cohort 3 | Experimental | Drug: REGN6490, Drug: PlaceboSingle ascending subcutaneous (SC) dose 3 of REGN6490 or matching placebo |
| Cohort 4 | Experimental | Drug: REGN6490, Drug: PlaceboSingle ascending intravenous (IV) dose 4 of REGN6490 or matching placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is a male or female first-generation Japanese participant 20 to 60 years of age (inclusive) at screening visit. First-generation Japanese subject must: (a) Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan, (b) Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet, (c) Have lived <10 years outside of Japan
- Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug
- Is in good health based on laboratory safety testing obtained at the screening visit
- Willing and able to comply with clinic visits and study-related procedures
Key exclusion criteria (6 listed)
- History of clinically significant cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
- Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation
- Hospitalization (>24 hours) for any reason within 30 days of the screening visit
- Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit
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 |
|---|---|---|
| REGN6490Single dose of REGN6490 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboPlacebo matching single dose of REGN6490 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 16
TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)
2 secondary outcomes
Serum Concentration of REGN6490 over time
Time frame: Up to Week 16
Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)
Time frame: Up to Week 16
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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.
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 REGN6490 in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 11 Nov 2021. 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 States. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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 and severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Week 16). 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 11 Nov 2021.