NCT03110549

Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Single Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Subcutaneously and Intramuscularly Administered TMB-607 in HIV-Negative Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: TaiMed Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.

Detailed description

This study uses a sequential dose-escalation design for single dose subcutaneous and intramuscular administrations in HIV-negative volunteers. The study investigates seven TMB-607 dose groups: Cohort 1: 200 mg subcutaneously (Arm A), 500 mg subcutaneously (Arm B) and 1,000 mg subcutaneously (Arm C); Cohort 2: 100 mg intramuscularly (Arm A), 400 mg intramuscularly (Arm B), 800 mg intramuscularly (Arm C) and 1,500 mg intramuscularly (Arm D). Five participants will be enrolled in each dose group, and will be randomly assigned in a 4:1 ratio to receive TMB-607 or placebo in a double-blinded fashion (four participants per group assigned to active TMB-607; one participant per group assigned to placebo). In each group, a single dose injection of TMB-607 or placebo will be administered at Day 0. The first three Day 0 injections administered in each dose group must be given at least 24 hours apart. Subjects will be enrolled sequentially so that a maximum of three subjects in each Cohort is dosed within any 24-hour period. All subjects will be monitored for 24 hours after study drug administration, with vital signs and ECGs checked hourly, and intensive pharmacokinetic samples collected during this period. Study drug will only be administered on Mondays to prevent weekend days from interfering with the daily assessments closest to the time of dosing. Participants will be followed for 10 weeks after receiving study drug.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	TMB-607
DRUG	Placebo

Timeline

• Start date: 2016-11-21
• Primary completion: 2019-07-22
• Completion: 2019-07-22
• First posted: 2017-04-12
• Last updated: 2020-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study