NCT04027387

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

A Phase Placebo-Controlled, Sequential Single Dose Escalation Study of the Safety, Pharmacokinetics, and Antiretroviral Activity of IVTMB-365 in HIV-1 Infected Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: TaiMed Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation study will evaluate the safety, tolerability and pharmacokinetic (PK) parameters of TMB-365 administered via intravenous infusion (IV) to HIV-1 infected participants at one of three successively increasing dose levels: 400 mg, 800 mg, and 1600 mg. Each participant will be monitored for 10 weeks post-administration. All participants will be expected to participate in PK sampling during Weeks 1, 4, 5, and 6. Beginning with the lowest dosage group, a Data Monitoring Committee (DMC) will review available data after four participants have completed two weeks of post-dose follow-up to determine if dosing of the next dosage group may proceed. If no dose limiting toxicities (DLTs) emerge, defined as a single Grade 4 or two of the same Grade 3 clinical or laboratory adverse events deemed possibly, probably or definitely related to the study drug, or a serious adverse event deemed possibly, probably or definitely related to the study drug as graded by the DAIDS Table for Grading Severity of Adult and Pediatric Adverse Events Version 2.1, then dosing of the next higher dose group will be permitted. Dosing in the highest dose group will begin after four of the eight participants in second group have successfully completed the scheduled study drug administration and two weeks of follow-up, and those data, along with all available data from the initial dose group have been reviewed by the DMC and no DLTs or SAEs as defined above are identified. All participants may initiate standard combination antiretroviral therapy six weeks after receiving the study drug.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	TMB-365	An IgG1 monoclonal antibody targeting domain 2 of the CD4 receptor for treatment of HIV-1 infection

Timeline

• Start date: 2019-12-14
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2019-07-22
• Last updated: 2021-10-06

Locations

6 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study