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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers

NCT ID: NCT04601844

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-07-23

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Cemdisiran at dose 1 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29

Group Type EXPERIMENTAL

Pozelimab

Intervention Type DRUG

Single dose administered subcutaneously

Cemdisiran

Intervention Type DRUG

Single dose administered SC

Cohort 2

Cemdisiran at dose 2 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29

Group Type EXPERIMENTAL

Pozelimab

Intervention Type DRUG

Single dose administered subcutaneously

Cemdisiran

Intervention Type DRUG

Single dose administered SC

Cohort 3

Cemdisiran at dose 2 SC single dose and pozelimab at dose 2 SC single dose, both administered on day 1

Group Type EXPERIMENTAL

Pozelimab

Intervention Type DRUG

Single dose administered subcutaneously

Cemdisiran

Intervention Type DRUG

Single dose administered SC

Interventions

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Pozelimab

Single dose administered subcutaneously

Intervention Type DRUG

Cemdisiran

Single dose administered SC

Intervention Type DRUG

Other Intervention Names

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REGN3918 ALN-CC5

Eligibility Criteria

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Inclusion Criteria

1. Has a body mass index less than 30 kg/m2 at the screening visit
2. Judged to be in good health as defined in the protocol
3. 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
4. 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
5. Must have two negative COVID-19 tests taken 48 hours apart and within 7 days prior to study drug administration

Exclusion Criteria

1. 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
2. Hospitalization (\>24 h) for any reason within 30 days of the screening visit
3. 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
4. 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
5. 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
6. Known or suspected COVID-19 disease
7. Known allergy or intolerance to penicillin class antibiotics or macrolides
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Research Site

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2020-000300-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R3918-HV-1982

Identifier Type: -

Identifier Source: org_study_id