NCT05976373

Brief Summary

This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2015

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 4, 2023

Status Verified

July 8, 2023

Enrollment Period

3 months

First QC Date

July 28, 2023

Last Update Submit

July 28, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Maximum serum concentration of functional dupilumab (Cmax)

    Pre-dose on Day 1 up to Day 57

  • Time to reach Cmax (Tmax)

    Pre-dose on Day 1 up to Day 57

  • Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)

    Pre-dose on Day 1 up to Day 57

Secondary Outcomes (2)

  • Incidence of treatment-emergent adverse events (TEAEs)

    Day 1 up to Day 57

  • Incidence of anti-dupilumab antibodies (ADA)

    Day 1 up to Day 57

Study Arms (2)

Dupilumab drug product 1

ACTIVE COMPARATOR

A single subcutaneous injection on Day 1

Drug: Dupilumab (SAR231893)

Dupilumab drug product 2

EXPERIMENTAL

A single subcutaneous injection on Day 1

Drug: Dupilumab (SAR231893)

Interventions

Dupilumab (SAR231893)DRUG

injection solution subcutaneous

Also known as: REGN668
Dupilumab drug product 1Dupilumab drug product 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants, between 18 and 65 years of age, inclusive.
  • Body weight between 70.0 and 90.0 kg, inclusive.
  • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
  • Having given written informed consent prior to undertaking any study-related procedure.

You may not qualify if:

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
  • Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
  • History of light-headedness or syncope during blood collection or injection of medications.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
  • History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
  • If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breast-feeding.
  • Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prism Research-Site Number:840001

Saint Paul, Minnesota, 55144, United States

Location

MeSH Terms

Interventions

dupilumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 4, 2023

Study Start

January 5, 2015

Primary Completion

March 30, 2015

Study Completion

March 30, 2015

Last Updated

August 4, 2023

Record last verified: 2023-07-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)