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Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants

NCT04027387 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-10-06

No results posted yet for this study

Summary

This study will evaluate the safety and behavior in the body of the experimental drug TMB-365 in people with HIV-1 infection. This will be the first test of TMB-365 in humans. One dose of the study drug is given to each participant, followed by 10 weeks of monitoring for safety and levels of the drug in the blood. The first group of participants will receive the lowest dose (400 mg). If no safety concerns are seen, the next group will begin at a higher dose (800 mg). If no safety concerns are seen in the second group, the third group will begin at the highest dose in this study (1600 mg).

Conditions

Interventions

BIOLOGICAL

TMB-365

An IgG1 monoclonal antibody targeting domain 2 of the CD4 receptor for treatment of HIV-1 infection

Sponsors & Collaborators

  • Westat

    collaborator OTHER

  • TaiMed Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Steve Weinheimer, PhD · TaiMed Biologics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-14
Primary Completion
2021-08-18
Completion
2021-08-18
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027387 on ClinicalTrials.gov