InfectionsPhase 1NCT01949103
TD-1607 MAD Study in Healthy Subjects
A Phase 1 study testing TD-1607 in people with Infections and Bacterial Infections, run by Theravance Biopharma at 1 site in United States.
Trial summary
TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Bacterial Infections
- What is being tested?
- TD-1607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2014
- 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
- Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
- Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.
- Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.
Who cannot join
- Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
- Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
- Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
- Subject has previously participated in a trial for TD-1607.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects
TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
- Conditions
- Infections, Bacterial Infections
- Being tested
- TD-1607, Placebo
- Keywords
- Gram-positive
- Medical subject headings
- Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1607Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TD-1607 or placebo (Dose1) | Experimental | TD-1607 or placebo administered intravenously Receives: Drug: TD-1607; Drug: Placebo |
| TD-1607 or placebo (Dose 2) | Experimental | TD-1607 or placebo administered intravenously Receives: Drug: TD-1607; Drug: Placebo |
| TD-1607 or placebo (Dose 3) | Experimental | TD-1607 or placebo administered intravenously Receives: Drug: TD-1607; Drug: Placebo |
| TD-1607 or placebo (Dose 4) | Experimental | TD-1607 or placebo administered intravenously Receives: Drug: TD-1607; Drug: Placebo |
| TD-1607 or placebo (Dose 5) [Optional] | Experimental | TD-1607 or placebo administered intravenously Receives: Drug: TD-1607; Drug: Placebo |
| TD-1607 or placebo (Dose 6) [Optional] | Experimental | TD-1607 or placebo administered intravenously Receives: Drug: TD-1607; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Adverse events
Measured: 17 days
Secondary outcomes (12)
Cmax
Pharmacokinetics
Measured: 17 Days
Tmax
Pharmacokinetics
Measured: 17 Days
AUC0-t
Pharmacokinetics
Measured: 17 Days
AUC0-24
Pharmacokinetics
Measured: 17 Days
AUCinf
Pharmacokinetics
Measured: 17 Days
CL
Pharmacokinetics
Measured: 17 Days
Vdss
Pharmacokinetics
Measured: 17 Days
t1/2
Pharmacokinetics
Measured: 17 Days
Amount excreted in urine (Ae
Pharmacokinetics
Measured: 17 Days
Fraction eliminated in urine (fe)
Pharmacokinetics
Measured: 17 Days
CLr
Pharmacokinetics
Measured: 17 Days
Ctrough
Pharmacokinetics
Measured: 17 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949103
- Sponsor's protocol ID
- 0104
- Status last verified
- Jan 2021
- First submitted
- 17 Sep 2013
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01949103
- Acronym / sponsor ID
- 0104
- Conditions
- Infections, Bacterial Infections
- Keywords
- Gram-positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- 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.
TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TD-1607 or placebo (Dose1) | Experimental | Drug: TD-1607, Drug: PlaceboTD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 2) | Experimental | Drug: TD-1607, Drug: PlaceboTD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 3) | Experimental | Drug: TD-1607, Drug: PlaceboTD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 4) | Experimental | Drug: TD-1607, Drug: PlaceboTD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 5) [Optional] | Experimental | Drug: TD-1607, Drug: PlaceboTD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 6) [Optional] | Experimental | Drug: TD-1607, Drug: PlaceboTD-1607 or placebo administered intravenously |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
- Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.
- Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.
Key exclusion criteria (4 listed)
- Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
- Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
- Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
- Subject has previously participated in a trial for TD-1607.
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 |
|---|---|---|
| TD-1607 | Drug | TD-1607 or placebo (Dose 2), TD-1607 or placebo (Dose 3), TD-1607 or placebo (Dose 4), TD-1607 or placebo (Dose 5) [Optional], TD-1607 or placebo (Dose 6) [Optional], TD-1607 or placebo (Dose1) |
| Placebo | Drug | TD-1607 or placebo (Dose 2), TD-1607 or placebo (Dose 3), TD-1607 or placebo (Dose 4), TD-1607 or placebo (Dose 5) [Optional], TD-1607 or placebo (Dose 6) [Optional], TD-1607 or placebo (Dose1) |
Primary outcome
Number of adverse events
Time frame: 17 days
Adverse events
12 secondary outcomes
Cmax
Time frame: 17 Days
Tmax
Time frame: 17 Days
AUC0-t
Time frame: 17 Days
AUC0-24
Time frame: 17 Days
AUCinf
Time frame: 17 Days
CL
Time frame: 17 Days
Vdss
Time frame: 17 Days
t1/2
Time frame: 17 Days
Amount excreted in urine (Ae
Time frame: 17 Days
Fraction eliminated in urine (fe)
Time frame: 17 Days
CLr
Time frame: 17 Days
Ctrough
Time frame: 17 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Medical Monitor study director
Theravance Biopharma
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 TD-1607 in people with Infections and Bacterial Infections, run by Theravance Biopharma 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jan 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adverse events (time frame: 17 days). 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 19 Jan 2021.