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Monoclonal Antibodies

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights
No Placebo-Only Group

Summary

This trial tests lab-made antibodies to help people at risk of or with HIV. The antibodies are designed to help the immune system recognize and fight the virus. Researchers are checking if these antibodies are safe and effective when given in different ways.

Eligible Conditions
  • Human Immunodeficiency Virus (HIV) Infection
  • HIV Suppression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Magnitude of serum neutralizing activity (ie, neutralizing antibody titers, including ID50, ID80) measured with monoclonal antibody mAb-specific Env-pseudotyped viruses in TZM-bl cells (in the validated TZM-bl pseudovirus neutralization assay) for Part A
Magnitude of serum neutralizing activity (ie, neutralizing antibody titers, including ID50, ID80) measured with monoclonal antibody mAb-specific Env-pseudotyped viruses in TZM-bl cells (in the validated TZM-bl pseudovirus neutralization assay) for Part B
Percentage of participants who experience local solicited adverse events (AEs) in Part A
+9 more
Secondary study objectives
Anti-drug antibodies (ADA) titers for participants in Part A
Anti-drug antibodies (ADA) titers for participants in Part B
Magnitude of neutralizing activity (i.e., neutralizing antibody titers, including ID50 and ID80) against a panel of Env-pseudotyped reference viruses in TZM-bl cells (in the validated TZM-bl pseudovirus neutralization assay) for participants in Part B
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups
Experimental Treatment
Group I: PGDM1400LS 5 mg/kg IVExperimental Treatment1 Intervention
Participants will receive PGDM1400LS 5 mg/kg by intravenous (IV) infusion at Month 0
Group II: PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg IVExperimental Treatment3 Interventions
Participants will receive PGDM1400LS 40mg/kg + VRC07-523LS 40mg/kg + PGT121.414.LS 40 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4
Group III: PGDM1400LS 40 mg/kg SCExperimental Treatment1 Intervention
Participants will receive PGDM1400LS 40 mg/kg by SC infusion at Month 0
Group IV: PGDM1400LS 40 mg/kg IVExperimental Treatment1 Intervention
Participants will receive PGDM1400LS 40 mg/kg by IV infusion at Month 0
Group V: PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg SCExperimental Treatment3 Interventions
Participants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by SC infusion sequentially in this order at Month 0 and Month 4
Group VI: PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg IVExperimental Treatment3 Interventions
Participants will receive PGDM1400LS 20mg/kg + VRC07-523LS 20mg/kg + PGT121.414.LS 20 mg/kg by IV infusion sequentially in this order at Month 0 and Month 4
Group VII: PGDM1400LS 20 mg/kg SCExperimental Treatment1 Intervention
Participants will receive PGDM1400LS 20 mg/kg by subcutaneous (SC) infusion at Month 0
Group VIII: PGDM1400LS 20 mg/kg IVExperimental Treatment1 Intervention
Participants will receive PGDM1400LS 20 mg/kg by IV infusion at Month 0
Group IX: PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram SCExperimental Treatment3 Interventions
Participants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by SC infusion sequentially in this order at Month 0 and Month 4
Group X: PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram IVExperimental Treatment3 Interventions
Participants will receive PGDM1400LS 1.4gram + VRC07-523LS 1.4gram + PGT121.414.LS 1.4gram by IV infusion sequentially in this order at Month 0 and Month 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PGT121.414.LS (1.4g, IV)
2021
Completed Phase 1
~100
PGT121.414.LS (1.4g, SC)
2021
Completed Phase 1
~100
VRC07-523LS (40mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (20mg/kg, SC)
2021
Completed Phase 1
~100
PGT121.414.LS (20mg/kg, SC)
2021
Completed Phase 1
~100
PGT121.414.LS (20mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (5mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (20mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (1.4g, SC)
2021
Completed Phase 1
~100
VRC07-523LS (1.4g, SC)
2021
Completed Phase 1
~100
PGT121.414.LS (40mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (40mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (40mg/kg, SC)
2021
Completed Phase 1
~100
VRC07-523LS (20mg/kg, SC)
2021
Completed Phase 1
~100
VRC07-523LS (20mg/kg, IV)
2021
Completed Phase 1
~100
PGDM1400LS (1.4g, IV)
2021
Completed Phase 1
~100
VRC07-523LS (1.4g, IV)
2021
Completed Phase 1
~100

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Department of Health and Human ServicesFED
232 Previous Clinical Trials
935,832 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,382,739 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,525 Total Patients Enrolled
Colleen KelleyStudy ChairEmory University
1 Previous Clinical Trials
30 Total Patients Enrolled
Marc SiegelStudy ChairGeorge Washington University
Sharana MahomedStudy ChairCentre for the AIDS Programme of Research in South Africa
~23 spots leftby Dec 2025
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