A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Single Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of the Intravenous Administration TMB-365 in HIV-1 Infected Participants

About this Study

The primary objectives of this study are to:
 Evaluate the safety and tolerability of a single IV infusion of TMB-365 in doses of 400 mg, 800 mg, and 1600 mg in HIV-1 infected participants

 Evaluate the pharmacokinetic (PK) profile of TMB-365 after a single IV infusion of doses of 400 mg, 800 mg, and 1600 mg in HIV-1 infected participants.

 Identify a suitable dose range of TMB-365 for further study.
The secondary objectives of this study are to:

 Evaluate the pharmacodynamic (PD) profile of TMB-365 after a single IV infusion of doses of 400 mg, 800 mg, and 1600 mg in HIV-1 infected participants.

 Evaluate the CD4 receptor density/occupancy in PBMCs of participants receiving a single IV infusion of doses of 400 mg, 800 mg, and 1600 mg of TMB-365.

 Evaluate the antiretroviral activity of TMB-365 after a single IV infusion of doses of 400 mg, 800 mg, and 1600 mg in HIV-1 infected participants.

Exploratory objectives of this study are to:
 Characterize the emergence of viral resistance to TMB-365 after a single IV infusion of doses of 400 mg, 800 mg, and 1600 mg in HIV-1 infected participants who meet criteria for virologic rebound.

 Determine the immunogenicity of TMB-365 after a single IV infusion of doses of 400 mg, 800 mg, and 1600 mg in HIV-1 infected participants.

Sponsor Protocol ID:TMB-365-101
IRB Number:2020-0186
Pending Activation
Interventional
Phase 1
July 17, 2020
Eligibility Criteria
Both Male and Female
Yes
No
No

Inclusion Criteria
Participants must meet all of the following criteria to be included in the study:

1. Male or female at least 18 years of age and no greater than 60 years on the day of Screening.

2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.

3. In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed.

4. Females of childbearing potential, sexually active with a male sex partner, must agree to use one effective method of contraception from the time of signing the consent to completion of the study, and agree to pregnancy testing as per the Schedule of Events and Procedures. Females of childbearing potential are female participants who are not surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), are not postmenopausal (at least one year without menses), and are not otherwise sterile by medical evaluation.

Exclusion Criteria1. Pregnant, planning a pregnancy during the trial period, or lactating.

2. Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation, or known allergy to an MAb.

3. Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt in the previous three years.

4. Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to the first dose.

5. Receipt of immunomodulatory agents (e.g., interleukins, interferons, cyclosporine, high dose systemic corticosteroids), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 180 days prior to the first dose.

6. Any chronic or acute medical condition, including drug use and alcohol abuse, which in the opinion of the investigator would interfere with evaluation of the study drug.

7. Lack of adequate venous access.

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Infectious Diseases
Participating Locations
Jackson Medical Mall - UMMC Clinics
Pavilion - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jennifer Brumfield
Phone Number: 601-984-4891
Email: jbrumfield@umc.edu
Principal Investigator:Leandro Mena
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