ThrombosisPhase 1TS23Phase1aNCT03001544
Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer
A Phase 1 study testing TS23 in people with Thrombosis and Cerebral Ischemia, run by Translational Sciences, Inc..
Trial summary
This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Cerebral Ischemia, Venous Thrombosis
- What is being tested?
- TS23
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 2017
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to provide written informed consent
- Healthy males age 18 years to 60 years of age
- Body mass index ≥ 20 and ≤ 33 kg/m squared
Who cannot join
- Known allergies or hypersensitivities to blood products or derivatives or therapeutic proteins or product excipients or components of CHO cells
- Current alcohol or drug abuse or history of alcohol or drug abuse
- Participation in any trial with an investigational drug within 90 days prior to dosing
- Blood donation of more than 500 mL of blood within 90 days prior to dosing
- Any history of a bleeding or thrombotic disorder
- Any history of significant cardiac, pulmonary, renal, hepatic, neurologic, or immunologic disorder
Show all 17Show fewer
- Over-the-counter medications, dietary supplements and herbal products (except a daily vitamin) within 14 days of drug administration or during the study
- No prescription medication for at least 14 days or 5-half-lives, whichever is longer, prior to study drug administration.
- Use of anticoagulants, fibrinolytic agents or non-steroidal anti-inflammatory medicines (except aspirin doses of 82 mg per day or less) for 2 weeks prior to and during the study
- Known hereditary fructosemia (due to sorbitol in the formulation)
- Any previous or current monoclonal antibody therapy
- History of trauma or surgery within the past 60 days or planned surgery within 30 days
- Abnormal baseline laboratory values or any laboratory values deemed clinically significant by the Investigator
- Recent history of head trauma in last 30 days prior to receiving TS23
- Unwillingness or inability to avoid contact sports or other activities with more than a small risk of head or facial trauma within 30 days of receiving TS23
- History of or risk of falls (e.g., due to dementia, frailty, etc.)
- Sexually active subjects must agree to use a reliable method of birth control (abstinence, condoms, vasectomy) and to not donate sperm for 3 months after receiving TS23
About this study
Official title: Phase 1 Single-ascending Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Anti-alpha2-antiplasmin (α2AP) Monoclonal Antibody TS23 in Healthy Human Volunteers
This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.
Read the detailed description
This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha 2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose trial at one clinical center.
- Conditions
- Thrombosis, Cerebral Ischemia, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction
- Being tested
- TS23
- Medical subject headings
- Thrombosis, Brain Ischemia, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS23Biological
comparison of different doses
| Study group | Role | What they receive |
|---|---|---|
| Experimental Ascending Dose Cohort | Experimental | TS23 Receives: Biological: TS23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events post-dose
To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose
Measured: 10 weeks
Secondary outcomes (6)
Coagulation (fibrinogen, PT, aPTT)
Measured: 10 weeks
Anti-drug antibody
Measured: 16 weeks
alpha2-antiplasmin activity
Measured: 10 weeks
D-dimer
Measured: 10 weeks
Pharmacokinetic parameter, maximum concentration of TS23
Pharmacokinetic parameter Cmax of TS23 in plasma
Measured: 10 weeks
Pharmacokinetic parameter, half-life of TS23
Pharmacokinetic parameter, time required for TS23 concentrations to fall by half
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001544
- Sponsor's protocol ID
- TS CP01-2015
- Acronym
- TS23Phase1a
- Status last verified
- Dec 2016
- First submitted
- 11 Nov 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single-ascending Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Anti-alpha2-antiplasmin (α2AP) Monoclonal Antibody TS23 in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT03001544
- Acronym / sponsor ID
- TS23Phase1a / TS CP01-2015
- Conditions
- Thrombosis, Cerebral Ischemia, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Translational Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 23 Dec 2016 (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.
This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.
Detailed description
This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha 2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose trial at one clinical center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Ascending Dose Cohort | Experimental | Biological: TS23TS23 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to provide written informed consent
- Healthy males age 18 years to 60 years of age
- Body mass index ≥ 20 and ≤ 33 kg/m squared
Key exclusion criteria (17 listed)
- Known allergies or hypersensitivities to blood products or derivatives or therapeutic proteins or product excipients or components of CHO cells
- Current alcohol or drug abuse or history of alcohol or drug abuse
- Participation in any trial with an investigational drug within 90 days prior to dosing
- Blood donation of more than 500 mL of blood within 90 days prior to dosing
- Any history of a bleeding or thrombotic disorder
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 |
|---|---|---|
| TS23comparison of different doses | Biological | Experimental Ascending Dose Cohort |
Primary outcome
Number and severity of adverse events post-dose
Time frame: 10 weeks
To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose
6 secondary outcomes
Coagulation (fibrinogen, PT, aPTT)
Time frame: 10 weeks
Anti-drug antibody
Time frame: 16 weeks
alpha2-antiplasmin activity
Time frame: 10 weeks
D-dimer
Time frame: 10 weeks
Pharmacokinetic parameter, maximum concentration of TS23
Time frame: 10 weeks
Pharmacokinetic parameter, half-life of TS23
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TS23 in people with Thrombosis and Cerebral Ischemia, run by Translational Sciences, Inc..
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 17 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: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number and severity of adverse events post-dose (time frame: 10 weeks). 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 23 Dec 2016.