HealthyPhase 1NCT04601844
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers
A Phase 1 study testing Pozelimab and Cemdisiran in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of ascending doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Nov 2020to 23 Jul 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index less than 30 kg/m2 at the screening visit
- Judged to be in good health as defined in the protocol
- Is in good health based on laboratory safety testing obtained at the screening visit NOTE: Subject with a history of Gilbert's disease can be enrolled in the study
- Willing to undergo vaccination against Neisseria meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit
- Must have two negative COVID-19 tests taken 48 hours apart and within 7 days prior to study drug administration
Who cannot join
- History of clinically significant cardiovascular, 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 subject by study participation
- Hospitalization (>24 h) 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 recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
- Is positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), hepatitis C antibody and positive for qualitative (ie, detected) HCV RNA test at the screening visit
- Within the previous 2 months of the screening visit has a history of bacterial, protozoal, parasitic or viral infection (including COVID-19) and/or persistent chronic or active recurring infection which requires treatment with antibiotics, antivirals, or antifungals
- Known or suspected COVID-19 disease
- Known allergy or intolerance to penicillin class antibiotics or macrolides
- NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of Subcutaneously Administered Human Monoclonal Antibody Pozelimab in Combination With Single Doses of Subcutaneously Administered siRNA Cemdisiran in Healthy Volunteers
The primary objective of the study is to evaluate the safety and tolerability of ascending doses of 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 assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart
- To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart
- To assess the immunogenicity of pozelimab and cemdisiran
- 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
Single dose administered subcutaneously
CemdisiranDrug
Also called ALN-CC5
Single dose administered SC
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cemdisiran at dose 1 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29 Receives: Drug: Pozelimab; Drug: Cemdisiran |
| Cohort 2 | Experimental | Cemdisiran at dose 2 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29 Receives: Drug: Pozelimab; Drug: Cemdisiran |
| Cohort 3 | Experimental | Cemdisiran at dose 2 SC single dose and pozelimab at dose 2 SC single dose, both administered on day 1 Receives: Drug: Pozelimab; Drug: Cemdisiran |
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)
Measured: Up to 20 weeks
Secondary outcomes (6)
Concentrations of pozelimab in serum over time
Measured: Up to 20 weeks
Concentrations of cemdisiran in plasma over time
Measured: Up to 20 weeks
Concentrations of total C5 over time
Measured: Up to 20 weeks
Change from baseline in total complement hemolytic activity assay (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 anti-drug antibodies (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 posted26 Oct 2020
- Study start16 Nov 2020
- Primary completion23 Jul 2021
- Study completion23 Jul 2021
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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alnylam Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601844
- Sponsor's protocol ID
- R3918-HV-1982
- Other IDs
- 2020-000300-11
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2020
- Last updated
- 12 Nov 2021
- 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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of Subcutaneously Administered Human Monoclonal Antibody Pozelimab in Combination With Single Doses of Subcutaneously Administered siRNA Cemdisiran in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04601844
- Acronym / sponsor ID
- R3918-HV-1982
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Alnylam Pharmaceuticals
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 26 Oct 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 ascending doses of 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 assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart
- To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart
- To assess the immunogenicity of pozelimab and cemdisiran
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Pozelimab, Drug: CemdisiranCemdisiran at dose 1 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29 |
| Cohort 2 | Experimental | Drug: Pozelimab, Drug: CemdisiranCemdisiran at dose 2 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29 |
| Cohort 3 | Experimental | Drug: Pozelimab, Drug: CemdisiranCemdisiran at dose 2 SC single dose and pozelimab at dose 2 SC single dose, both administered on day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has a body mass index less than 30 kg/m2 at the screening visit
- Judged to be in good health as defined in the protocol
- Is in good health based on laboratory safety testing obtained at the screening visit NOTE: Subject with a history of Gilbert's disease can be enrolled in the study
- Willing to undergo vaccination against Neisseria meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit
- Must have two negative COVID-19 tests taken 48 hours apart and within 7 days prior to study drug administration
Key exclusion criteria (8 listed)
- History of clinically significant cardiovascular, 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 subject by study participation
- Hospitalization (>24 h) 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 recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
- Is positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), hepatitis C antibody and positive for qualitative (ie, detected) HCV RNA test at the screening visit
- Within the previous 2 months of the screening visit has a history of bacterial, protozoal, parasitic or viral infection (including COVID-19) and/or persistent chronic or active recurring infection which requires treatment with antibiotics, antivirals, or antifungals
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: REGN3918Single dose administered subcutaneously | Drug | Cohort 1, Cohort 2, Cohort 3 |
| CemdisiranAlso: ALN-CC5Single dose administered SC | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 20 weeks
6 secondary outcomes
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
Concentrations of total C5 over time
Time frame: Up to 20 weeks
Change from baseline in total complement hemolytic activity assay (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 anti-drug antibodies (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 12 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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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 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 8 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 12 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 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?
Incidence and severity of treatment emergent adverse events (TEAEs) (time frame: Up to 20 weeks). 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 12 Nov 2021.