Human Immunodeficiency VirusPhase 1NCT03110549
Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers
A Phase 1 study testing TMB-607 in people with Human Immunodeficiency Virus, run by TaiMed Biologics Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- TMB-607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 22 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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
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.
Read the 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
- Being tested
- TMB-607, Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMB-607Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Arm A | Experimental | Subcutaneous 200 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
| Cohort 1 Arm B | Experimental | Subcutaneous 500 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
| Cohort 1 Arm C | Experimental | Subcutaneous 1000 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
| Cohort 2 Arm A | Experimental | Subcutaneous 100 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
| Cohort 2 Arm B | Experimental | Subcutaneous 400 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
| Cohort 2 Arm C | Experimental | Subcutaneous 800 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
| Cohort 2 Arm D | Experimental | Subcutaneous 1500 mg of TMB-607 on Day 0 or Placebo Receives: Drug: TMB-607; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Weeks Post Injection
Secondary outcomes (1)
Adverse Events Related to Treatment
The frequency of adverse events will be tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) term and system organ class. The maximum intensity and frequency of adverse events will be summarized by treatment group
Measured: 10 Weeks Post Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start21 Nov 2016
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Why it stopped: Drug development suspended by current holder of IND
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiMed Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Jacobson, MD, Principal investigator, Lewis Katz School of Medicine at Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110549
- Sponsor's protocol ID
- TMB 607 101
- Status last verified
- May 2020
- First submitted
- 31 Mar 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03110549
- Acronym / sponsor ID
- TMB 607 101
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug development suspended by current holder of IND
- Enrolment
- 9 participants (actual)
- Lead sponsor
- TaiMed Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Arm A | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 200 mg of TMB-607 on Day 0 or Placebo |
| Cohort 1 Arm B | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 500 mg of TMB-607 on Day 0 or Placebo |
| Cohort 1 Arm C | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 1000 mg of TMB-607 on Day 0 or Placebo |
| Cohort 2 Arm A | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 100 mg of TMB-607 on Day 0 or Placebo |
| Cohort 2 Arm B | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 400 mg of TMB-607 on Day 0 or Placebo |
| Cohort 2 Arm C | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 800 mg of TMB-607 on Day 0 or Placebo |
| Cohort 2 Arm D | Experimental | Drug: TMB-607, Drug: PlaceboSubcutaneous 1500 mg of TMB-607 on Day 0 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following criteria to be included in the study:
Key exclusion criteria (15 listed)
- Participants having or meeting any of the following conditions or characteristics will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
TMB 607 plasma concentrations
Time frame: 10 Weeks Post Injection
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.
1 secondary outcome
Adverse Events Related to Treatment
Time frame: 10 Weeks Post Injection
Results and safety
The study was stopped early (reason given: Drug development suspended by current holder of IND). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Jacobson, MD principal investigator
Lewis Katz School of Medicine at Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMB-607 in people with Human Immunodeficiency Virus, run by TaiMed Biologics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Drug development suspended by current holder of IND). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMB 607 plasma concentrations (time frame: 10 Weeks Post Injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.