Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults

Completed · Phase 1

Conditions studied: HIV Infection, Monoclonal Antibody, Human, HIV Antibodies, VRC01 Monoclonal Antibody, Neutralizing Antibody

In brief

Background: \- VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection. In this study they want to know if the study drug is safe if taken in a vein or under the skin. Taking VRC01 in this study will not protect against HIV infection. Objectives: \- To see if VRC01 and placebo are safe and well tolerated. Eligibility: \- Healthy adults 18 to 50 years old. Design: * Participants will be screened with medical history, physical exam, and lab tests. * Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo dose. * Three groups will receive VRC01 by needle into a vein with an IV pump. It will take about 1 hour and it is done in the hospital. * One group will receive either VRC01 or the placebo by needle into the fatty tissue under the skin, usually the belly. It will take up to 20 minutes and it is done in the hospital. * Participants will stay in the hospital overnight after receiving the medication and have about 14 clinic visits over 4 months. Most clinic visits last about 2 hours. * Participants will keep a symptom diary after receiving the medicatino. * Participants can volunteer to have mouth, rectal, and genital samples taken throughout the study. * The study will last 8 months.

Key facts

Study ID

NCT01993706

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

29

Starts

2013-11-19

Expected to finish

2015-02-27

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply:
• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
• Weight >115 kg or <53 kg.
• History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence.
• Hypertension that is not well controlled.
• Woman who is breast-feeding, or planning to become pregnant during the 16 weeks of study participation.
• Receipt of any investigational study agent within 28 days prior to enrollment or any past receipt of an investigational HIV vaccine.
• Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. Including, but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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