HealthyPhase 1NCT00612196
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
A Phase 1 study testing TB-402 in people with Healthy, run by ThromboGenics at 1 site in Denmark.
Trial summary
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TB-402
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Dec 2007
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
- No clinically important abnormal physical, laboratory, ECG findings
- Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)
Who cannot join
- Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
- Any autoimmune disease.
- Previous allergic reaction to immunoglobulin.
- Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
- Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
- Abnormal platelet function or clinically significant out of range values for any coagulation tests.
- History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
- Screening FVIII:C < 50%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- TB-402, Placebo
- Keywords
- Safety and tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB-402Drug
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: TB-402 |
| 2 | Experimental | Not described Receives: Drug: TB-402 |
| 3 | Experimental | Not described Receives: Drug: TB-402 |
| 4 | Experimental | Not described Receives: Drug: TB-402 |
| 5 | Experimental | Not described Receives: Drug: TB-402 |
| 6 | Experimental | Not described Receives: Drug: TB-402 |
| 7 | Experimental | Not described Receives: Drug: TB-402 |
| 8 | Experimental | Not described Receives: Drug: TB-402 |
| 9 | Experimental | Not described Receives: Drug: TB-402 |
| 10 | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Investigators
- Thomas J Jensen, M.D., Principal investigator, Cyncron Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612196
- Sponsor's protocol ID
- TB-402-001
- Status last verified
- Apr 2014
- First submitted
- 9 Jan 2008
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Verhamme P, Pakola S, Jensen TJ, Berggren K, Sonesson E, Saint-Remy JM, Balchen T, Belmans A, Cahillane G, Stassen JM, Peerlinck K, Glazer S, Jacquemin M. Tolerability and pharmacokinetics of TB-402 in healthy male volunteers. Clin Ther. 2010 Jun;32(6):1205-20. doi: 10.1016/j.clinthera.2010.06.012.
PubMed 20637972
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT00612196
- Acronym / sponsor ID
- TB-402-001
- Conditions
- Healthy
- Keywords
- Safety and tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Study start
- Mar 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Feb 2008 (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.
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TB-402 |
| 2 | Experimental | Drug: TB-402 |
| 3 | Experimental | Drug: TB-402 |
| 4 | Experimental | Drug: TB-402 |
| 5 | Experimental | Drug: TB-402 |
| 6 | Experimental | Drug: TB-402 |
| 7 | Experimental | Drug: TB-402 |
| 8 | Experimental | Drug: TB-402 |
| 9 | Experimental | Drug: TB-402 |
| 10 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
- No clinically important abnormal physical, laboratory, ECG findings
- Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)
Key exclusion criteria (8 listed)
- Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
- Any autoimmune disease.
- Previous allergic reaction to immunoglobulin.
- Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
- Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
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 |
|---|---|---|
| TB-402Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes | Drug | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Placebo | Drug | 10 |
Primary outcome
Not reported in the source record.
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 7 Apr 2014.
- Derived from this study: PubMed 20637972Verhamme P, Pakola S, Jensen TJ, Berggren K, Sonesson E, Saint-Remy JM, Balchen T, Belmans A, Cahillane G, Stassen JM, Peerlinck K, Glazer S, Jacquemin M. Tolerability and pharmacokinetics of TB-402 in healthy male volunteers. Clin Ther. 2010 Jun;32(6):1205-20. doi: 10.1016/j.clinthera.2010.06.012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Thomas J Jensen, M.D. principal investigator
Cyncron Clinical Research Unit
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 TB-402 in people with Healthy, run by ThromboGenics at 1 site in Denmark.
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 8 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 7 Apr 2014. 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 Denmark. 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00612196, which also lists 1 linked publication.
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 7 Apr 2014.