Ascending Dose Study of the Safety and Tolerability of RE... | NCT04616079

Studies
Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers

NCT04616079

Sponsor

Regeneron Pharmaceuticals

Status

Terminated

Last Update Posted

Nov 11, 2021Actual

Enrollment

57Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

REGN6490
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-003261-19	EudraCT Number

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Nov 19, 2020Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Oct 29, 2020

First Submission Date that Met QC Criteria

Oct 29, 2020

First Posted Date

Nov 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2021

Last Update Posted Date

Nov 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants

The secondary objectives of the study are to:

Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants
Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IV Cohort 1	Experimental	Single intravenous (IV) dose 1 of REGN6490 or matching placebo	Drug: REGN6490 Drug: Placebo
IV Cohort 2	Experimental	Single IV dose 2 of REGN6490 or matching placebo	Drug: REGN6490 Drug: Placebo
IV Cohort 3	Experimental	Single IV dose 3 of REGN6490 or matching placebo	Drug: REGN6490 Drug: Placebo
IV Cohort 4	Experimental	Single IV dose 4 of REGN6490 or matching placebo	Drug: REGN6490 Drug: Placebo
IV Cohort 5	Experimental	Single IV dose 5 of REGN6490 or matching placebo	Drug: REGN6490 Drug: Placebo
SC Cohort 1	Experimental	Single subcutaneous (SC) dose 1 of REGN6490 or matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
REGN6490	Drug	Single dose of REGN6490	IV Cohort 1 IV Cohort 2 IV Cohort 3 IV Cohort 4 IV Cohort 5 SC Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)	TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)	Up to Week 16

Secondary Outcomes

Measure	Description	Time Frame
Serum Concentration of REGN6490 over time		Up to Week 16
Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)		Up to Week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

Access Criteria

Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (eg, FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

URL

https://vivli.org/