HealthyPhase 1NCT04940364
A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers
A Phase 1 study testing Pozelimab and Cemdisiran in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pozelimab and Cemdisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2021to 22 Jun 2022
- 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
- Japanese participant must be:
- Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan
- Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet
- Living < 10 years outside of Japan
- Has a Body Mass Index (BMI) between 18 and 30 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 ECGs performed at screening and/or prior to administration of initial dose of study drug
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- Is in good health based on laboratory safety testing obtained at the screening visit Note: Participant with suspected or confirmed Gilbert's disease can be enrolled in the study
- Willing to undergo vaccination against N. meningitidis unless participant has documentation of completed series of vaccinations within the past 2 years of the screening visit
- Must have two consecutive negative COVID-19 tests at least 48 hours apart and within 7 days prior to study drug administration Note: The test may be the point of care quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) test or approved COVID-19 antigen test at the discretion of the investigator.
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator as defined in the protocol
- 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
- Hospitalization (>24 hour) for any reason within 30 days of the screening visit
- Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; or a history of alcohol and/or drug abuse within a year prior to the screening visit
- Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at the screening visit
- Is positive for hepatitis C antibody and positive for qualitative (i.e., detected) hepatitis C virus (HCV) RNA test at the screening visit
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- Within the previous 2 months of the screening visit has a history of bacterial, protozoal, viral or parasite infection (including COVID-19) and/or persistent chronic or active recurring infection which require treatment with antibiotics, antivirals, or antifungals
- Known or suspected COVID-19 disease at screening and/or prior to 1st dose administration
- NOTE: Other protocol-defined Inclusion and Exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Parallel-Dose Study of the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Japanese Healthy Volunteers
The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.
The secondary objectives of the study are:
- To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants
- To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants
- To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants
- Conditions
- Healthy
- Being tested
- Pozelimab, Cemdisiran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PozelimabDrug
Also called REGN3918
Administered intravenous (IV) or subcutaneous (SC) per protocol
CemdisiranDrug
Also called ALN-CC5
Administered SC per protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Pozelimab: Single-dose SC on day 1 Receives: Drug: Pozelimab |
| Cohort 2 | Experimental | Pozelimab: Single-dose IV on day 1 Receives: Drug: Pozelimab |
| Cohort 3 | Experimental | Pozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1 Receives: Drug: Pozelimab; Drug: Cemdisiran |
| Cohort 4 | Experimental | Pozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1 Receives: Drug: Pozelimab; Drug: Cemdisiran |
| Cohort 5 | Experimental | Optional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1 Receives: Drug: Pozelimab; Drug: Cemdisiran |
| Cohort 6 | Experimental | Pozelimab: Single-dose IV on day 1 Receives: Drug: Pozelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of pozelimab in serum over time
Measured: Up to 20 weeks
Concentrations of cemdisiran in plasma over time.
Measured: Up to 20 weeks
Secondary outcomes (5)
The incidence and severity of treatment-emergent adverse events (TEAE) in subjects administered pozelimab with/without cemdisiran
Measured: Up to 20 weeks
Concentrations of total C5 in plasma over time
Measured: Up to 20 weeks
Change from baseline in CH50 over time
Measured: Up to 20 weeks
Incidence of treatment-emergent anti-drug antibodies (ADA) to pozelimab
Measured: Up to 20 weeks
Incidence of treatment-emergent ADA to cemdisiran
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 posted25 Jun 2021
- Study start4 Aug 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04940364
- Sponsor's protocol ID
- R3918-HV-20117
- Other IDs
- 2021-001794-23
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Parallel-Dose Study of the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Japanese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04940364
- Acronym / sponsor ID
- R3918-HV-20117
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 25 Jun 2021 (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 assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.
The secondary objectives of the study are:
- To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants
- To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants
- To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PozelimabPozelimab: Single-dose SC on day 1 |
| Cohort 2 | Experimental | Drug: PozelimabPozelimab: Single-dose IV on day 1 |
| Cohort 3 | Experimental | Drug: Pozelimab, Drug: CemdisiranPozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1 |
| Cohort 4 | Experimental | Drug: Pozelimab, Drug: CemdisiranPozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1 |
| Cohort 5 | Experimental | Drug: Pozelimab, Drug: CemdisiranOptional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1 |
| Cohort 6 | Experimental | Drug: PozelimabPozelimab: Single-dose IV on day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Japanese participant must be:
- Has a Body Mass Index (BMI) between 18 and 30 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 ECGs 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 Note: Participant with suspected or confirmed Gilbert's disease can be enrolled in the study
- Willing to undergo vaccination against N. meningitidis unless participant has documentation of completed series of vaccinations within the past 2 years of the screening visit
Key exclusion criteria (9 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator as defined in the protocol
- 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
- Hospitalization (>24 hour) for any reason within 30 days of the screening visit
- Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; or a history of alcohol and/or drug abuse within a year prior to the screening visit
- Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at 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 |
|---|---|---|
| PozelimabAlso: REGN3918Administered intravenous (IV) or subcutaneous (SC) per protocol | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| CemdisiranAlso: ALN-CC5Administered SC per protocol | Drug | Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Concentrations of pozelimab in serum over time
Time frame: Up to 20 weeks
Concentrations of cemdisiran in plasma over time.
Time frame: Up to 20 weeks
5 secondary outcomes
The incidence and severity of treatment-emergent adverse events (TEAE) in subjects administered pozelimab with/without cemdisiran
Time frame: Up to 20 weeks
Concentrations of total C5 in plasma over time
Time frame: Up to 20 weeks
Change from baseline in CH50 over time
Time frame: Up to 20 weeks
Incidence of treatment-emergent anti-drug antibodies (ADA) to pozelimab
Time frame: Up to 20 weeks
Incidence of treatment-emergent ADA to cemdisiran
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 6 Jul 2022.
- 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. 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 Pozelimab and Cemdisiran in people with Healthy, 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 9 inclusion and 9 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 6 Jul 2022. 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?
Concentrations of pozelimab in serum over time (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?
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 6 Jul 2022.