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OpenTrials
Completed

NCT Number: NCT03645746

Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.

The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Regeneron Research Facility

Ghent, B-9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing
  • Participant 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 or legally acceptable representative

Key Exclusion Criteria:

  • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease
  • Has any physical examination findings and/or history of any illness that might confound the results of the study or poses an additional risk to the subject by study participation
  • Hospitalization for any reason within 60 days of the screening visit
  • Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening
  • History of drug or alcohol abuse within a year prior to the screening visit
  • Presence of HIV, hepatitis B, or hepatitis C seropositivity at screening or within 3 months prior to dosing with the exception of false positive screening tests as documented by polymerase chain reaction or Western blot
  • Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus, that have been resected, with no evidence of metastatic disease for 3 years

Note: Other protocol Inclusion/Exclusion Criteria apply

Treatment and study plan

REGN5069

Drug

REGN5069 will be administered by IV infusion or SC injection

Placebo

Drug

Placebo-matching REGN5069

Primary outcomes

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Time frame: From baseline up to week 36

  2. Incidence of laboratory abnormalities

    Time frame: From baseline up to week 36

    As measured by chemistry, hematology and urinalysis

  3. Incidence of vital signs abnormalties

    Time frame: From baseline up to week 36

    As measured by heart rate, blood pressure, body temperature and respiratory rate

  4. Incidence of standard 12-lead electrocardiogram (ECG) abnormalties

    Time frame: From baseline up to week 36

    As measured by heart rate, PR, complex of Q, R, and S waves [QRS], QT-intervals, and QTc

Secondary outcomes

  1. Concentration of REGN5069 in serum over time

    Time frame: From baseline up to week 36

  2. Incidence of anti-drug antibody (ADA)

    Time frame: From baseline up to week 36

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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