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

NCT03110549 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus

Interventions

DRUG

TMB-607

DRUG

Placebo

Sponsors & Collaborators

  • TaiMed Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Jacobson, MD · Lewis Katz School of Medicine at Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2019-07-22
Completion
2019-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03110549 on ClinicalTrials.gov