ACTIVE_NOT_RECRUITING

Study of a Human Bispecific Antibody VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults

Conditions

HIV Infection Immune Response HIV Bi-Specific Antibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immunodeficiency syndrome). Researchers want to find new ways to treat or prevent HIV infection. CAP256J3LS is a new product that uses antibodies. Antibodies are naturally occurring proteins; they target and disable disease-causing agents such as viruses. This new product may be able to stop HIV infections. Objective: To test the safety of CAP256J3LS in healthy people. Eligibility: People aged 18 to 60 years in good general health. Design: CAP256J3LS can be administered in 2 ways: (1) by a shot under the skin into the belly fat or (2) through a tube inserted into a vein in the arm. Participants will be divided into 6 groups: The study will open with the lowest dose of study product. The dose groups are spaced out to allow the study team to look over the safety data in each group. If there are no safety concerns in the lowest dose, then the next higher dose groups will be enrolled. This pattern will continue until all dose groups are enrolled.. Also, some participants will receive only 1 dose; others will receive 3 doses, each spaced 12 weeks apart. Those who receive only 1 dose of the study drug will have 14 clinic visits over 6 months. Those who get 3 doses will have 27 visits over 11 months. Participants will provide blood samples at each visit. Urine samples may also be needed. All participants will get a thermometer and a measuring tool. They will measure any redness, swelling, or bruising they have at the injection site. They will check their temperature every day for 7 days after receiving the study drug. They will record their highest temperatures and any symptoms they have. ...

Official Title

VRC 617: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety and Pharmacokinetics of a Human Bispecific Antibody, VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults

Quick Facts

Study Start:2024-10-07

Study Completion:2027-06-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06585891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Willing and able to complete the informed consent process. 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 3. Available for clinical follow-up through the last study visit. 4. 18 to 60 years of age. 5. In good general health without a clinically significant medical history. 6. Physical examination without clinically significant findings within the 56 days prior to enrollment. 7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to a SC group. 8. Willing to have blood samples collected, stored indefinitely, and used for research purposes. 9. White blood cell count (WBC): 2,500-12,000/mm\^3. 10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval, excluding absolute lymphocyte count which must not be lower than normal range. 11. Platelets: 125,000 - 400,000/mm\^3. 12. Hemoglobin within institutional normal range or is lower than normal range but does not meet Grade 1 criteria and is not clinically concerning. 13. Creatinine: \<= 1.1 x Upper Limit of Normal (ULN). 14. ALT: \<= ULN. 15. AST: \<= ULN. 16. ALP: \<= ULN. 17. Total bilirubin within institutional normal range or is outside normal range but does not meet Grade 1 criteria and is not clinically concerning 18. Direct bilirubin: \<= ULN 19. Negative HIV 1/2 Antibody/Ag test. 20. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation. 21. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.	1. Woman who is breast-feeding or planning to become pregnant during study participation. 2. Weight \> 115 kg. 3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study. 4. Hypertension that is not well controlled. 5. Receipt of any investigational study product within 28 days prior to enrollment. 6. Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody. 7. Receipt of any live attenuated vaccine within 28 days prior to enrollment. 8. Receipt of any vaccine within 2 weeks prior to enrollment. 9. Known history of Gilbert's syndrome. 10. Known history of kidney or liver disease. 11. Diabetes mellitus (type I or II), with the exception of a history of gestational diabetes. 12. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within 14 days prior to enrollment. 13. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 14. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to diabetes mellitus, hepatitis, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, cancer and clinically significant forms of drug or alcohol abuse.

Inclusion Criteria

Exclusion Criteria

1. Willing and able to complete the informed consent process.
2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
3. Available for clinical follow-up through the last study visit.
4. 18 to 60 years of age.
5. In good general health without a clinically significant medical history.
6. Physical examination without clinically significant findings within the 56 days prior to enrollment.
7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to a SC group.
8. Willing to have blood samples collected, stored indefinitely, and used for research purposes.
9. White blood cell count (WBC): 2,500-12,000/mm\^3.
10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval, excluding absolute lymphocyte count which must not be lower than normal range.
11. Platelets: 125,000 - 400,000/mm\^3.
12. Hemoglobin within institutional normal range or is lower than normal range but does not meet Grade 1 criteria and is not clinically concerning.
13. Creatinine: \<= 1.1 x Upper Limit of Normal (ULN).
14. ALT: \<= ULN.
15. AST: \<= ULN.
16. ALP: \<= ULN.
17. Total bilirubin within institutional normal range or is outside normal range but does not meet Grade 1 criteria and is not clinically concerning
18. Direct bilirubin: \<= ULN
19. Negative HIV 1/2 Antibody/Ag test.
20. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.
21. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

1. Woman who is breast-feeding or planning to become pregnant during study participation.
2. Weight \> 115 kg.
3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.
4. Hypertension that is not well controlled.
5. Receipt of any investigational study product within 28 days prior to enrollment.
6. Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.
7. Receipt of any live attenuated vaccine within 28 days prior to enrollment.
8. Receipt of any vaccine within 2 weeks prior to enrollment.
9. Known history of Gilbert's syndrome.
10. Known history of kidney or liver disease.
11. Diabetes mellitus (type I or II), with the exception of a history of gestational diabetes.
12. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within 14 days prior to enrollment.
13. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
14. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to diabetes mellitus, hepatitis, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, cancer and clinically significant forms of drug or alcohol abuse.

Contacts and Locations

Principal Investigator

Joseph P Casazza, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Joseph P Casazza, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-07

Study Completion Date2027-06-09

Study Record Updates

Study Start Date2024-10-07

Study Completion Date2027-06-09

Terms related to this study

Keywords Provided by Researchers

Immune Response
HIV
Bi-Specific Antibody

Additional Relevant MeSH Terms

HIV Infection