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

NCT03110549 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: TMB 607 101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• TMB 607 plasma concentrations

  Measurements of concentrations of TMB-607 in plasma will be used to determine the concentration-time profile of subcutaneous and intramuscular TMB-607 in all participants. TMB-607 plasma concentrations will be measured by a central lab using high-performance liquid chromatography - mass (HPLC-MS) method validated for the measurement of TMB-607 in human plasma.

  10 Weeks Post Injection

Secondary Outcomes (1)

• Adverse Events Related to Treatment

  10 Weeks Post Injection

Study Arms (7)

Cohort 1 Arm A

EXPERIMENTAL

Subcutaneous 200 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Cohort 1 Arm B

EXPERIMENTAL

Subcutaneous 500 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Cohort 1 Arm C

EXPERIMENTAL

Subcutaneous 1000 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Cohort 2 Arm A

EXPERIMENTAL

Subcutaneous 100 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Cohort 2 Arm B

EXPERIMENTAL

Subcutaneous 400 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Cohort 2 Arm C

EXPERIMENTAL

Subcutaneous 800 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Cohort 2 Arm D

EXPERIMENTAL

Subcutaneous 1500 mg of TMB-607 on Day 0 or Placebo

Drug: TMB-607; Drug: Placebo

Interventions

TMB-607 DRUG

Cohort 1 Arm A; Cohort 1 Arm B; Cohort 1 Arm C; Cohort 2 Arm A; Cohort 2 Arm B; Cohort 2 Arm C; Cohort 2 Arm D

Placebo DRUG

Cohort 1 Arm A; Cohort 1 Arm B; Cohort 1 Arm C; Cohort 2 Arm A; Cohort 2 Arm B; Cohort 2 Arm C; Cohort 2 Arm D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be included in the study:
• Male or female between 18-55 years of age on the day of screening
• HIV-negative volunteers, willing to undergo HIV testing and counseling, and receive HIV test results
• Normal 12-lead ECG at Screening and on Day 0, including normal sinus rate and rhythm, QTc interval ≤440msec, PR interval ≤200msec, and lack of any evidence of heart block, or left or right bundle branch block
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
• 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
• Agrees to use a barrier form of contraception if engaging in sexual activity at any time throughout the study (males and females) - two reliable forms of barrier contraception diaphragm, Intra Uterine Device (IUD), spermicides or condoms) must be used if participants engage in sexual activity that could result in pregnancy; hormonal contraception (e.g., oral contraceptive pill, injectable or implantable contraceptive) must not be relied upon while in this study; all female participants must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Events and Procedures
• For females of reproductive potential, negative urine pregnancy test at screening and within 96 hours prior to randomization; female participants of reproductive potential are defined as women who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, salpingectomy, or tubal ligation)

You may not qualify if:

• Participants having or meeting any of the following conditions or characteristics will be excluded from the study:
• Confirmed HIV-1 or HIV-2 infection
• Currently pregnant or breastfeeding
• Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation, or known allergy to sulfonamide drugs
• History, or family history of Short of Long QT syndrome, Wolff-Parkinson-White Syndrome, or congenital heart disease
• Family history of sudden cardiac death, or unexplained cardiac death in an otherwise healthy individual between the ages of 1 and 40 years
• History of syncope, palpitations, unexplained dizziness, hypokalemia, heart arrhythmias, or significant cardiac disease
• Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicide attempt in the previous 3 years
• Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to randomization
• Receipt of immunomodulatory agents (e.g., interleukins, interferons, cyclosporine, systemic corticosteroids), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 180 days prior to study entry
• Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
• Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity Criteria (Appendix A)
• Confirmed diagnosis of hepatitis B (surface antigen, HbsAg), or hepatitis C (HCV antibodies)
• Current confirmed STD infection
• In the opinion of the investigator, unlikely to comply with protocol

Sponsors & Collaborators

• TaiMed Biologics Inc.: lead

Study Sites (1)

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jeffrey Jacobson, MD

  Lewis Katz School of Medicine at Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Five qualifying participants will be enrolled into each of seven dosage Arms - three escalating subcutaneous dosages (Cohort 1), and four escalating intramuscular dosages (Cohort 2). Enrolling participants will be randomized to receive active TMB-607 or placebo. Beginning with the lowest dosage group, a Data Safety Monitoring Board (DSMB) will review available data after four participants have completed two weeks of post-dose follow-up to determine whether escalation to the next dosage group may proceed

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 12, 2017
• Study Start: November 21, 2016
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

US (1)