Cytomegalovirus InfectionsPhase 1NCT01594437
Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
A Phase 1 study testing TCN-202 in people with Cytomegalovirus Infections, run by Theraclone Sciences, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- TCN-202
- 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
- May 2012to Mar 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers
- Normal lab tests
Who cannot join
- Prior treatment with monoclonal antibody
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.
Read the detailed description
Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is ~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.
- Conditions
- Cytomegalovirus Infections
- Being tested
- TCN-202, Placebo
- Keywords
- Cytomegalovirus, Monoclonal antibody
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCN-202Biological
Also called Human Anti-Cytomegalovirus Monoclonal Antibody
Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.
PlaceboBiological
Also called 0.9% Sodium chloride for Injection, USP
One or two doses administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| TCN-202 | Experimental | Not described Receives: Biological: TCN-202 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events
Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).
Measured: 60 days post infusion
Secondary outcomes (4)
Peak serum concentration (Cmax) of TCN-202
Measured: 1 day post infusion
Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)
Immunogenicity will be assessed based on induction of TCN-202 anti-drug antibodies.
Measured: 60 days post infusion
Area under the concentration time curve (AUC) of TCN-202
Measured: 60 days post infusion
Time to maximum serum concentration (Tmax) of TCN-202
Measured: 1 day post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclone Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MD, FACP, Principal investigator, SNBL Clinical Pharmacology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594437
- Sponsor's protocol ID
- TCN-202-001
- Status last verified
- Mar 2014
- First submitted
- 5 May 2012
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01594437
- Acronym / sponsor ID
- TCN-202-001
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cytomegalovirus, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Theraclone Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 May 2012 (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.
The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.
Detailed description
Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is ~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCN-202 | Experimental | Biological: TCN-202 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers
- Normal lab tests
Key exclusion criteria (1 listed)
- Prior treatment with monoclonal antibody
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 |
|---|---|---|
| TCN-202Also: Human Anti-Cytomegalovirus Monoclonal AntibodyHuman monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion. | Biological | TCN-202 |
| PlaceboAlso: 0.9% Sodium chloride for Injection, USPOne or two doses administered by intravenous infusion. | Biological | Placebo |
Primary outcome
Number and severity of adverse events
Time frame: 60 days post infusion
Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).
4 secondary outcomes
Peak serum concentration (Cmax) of TCN-202
Time frame: 1 day post infusion
Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)
Time frame: 60 days post infusion
Area under the concentration time curve (AUC) of TCN-202
Time frame: 60 days post infusion
Time to maximum serum concentration (Tmax) of TCN-202
Time frame: 1 day post infusion
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 21 Mar 2014.
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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.
Mohamed Al-Ibrahim, MD, FACP principal investigator
SNBL Clinical Pharmacology Center
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 TCN-202 in people with Cytomegalovirus Infections, run by Theraclone Sciences, 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 2 inclusion and 1 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 21 Mar 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 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. 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.
What does the primary outcome measure?
Number and severity of adverse events (time frame: 60 days post infusion). 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 21 Mar 2014.