Congenital Bleeding DisorderPhase 1Explorer 1NCT01228669
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
A Phase 1 study testing NNC 0172-0000-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 16 sites in 11 countries.
Trial summary
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- NNC 0172-0000-2021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 16 sitesin 11 countries
- Study dates
- 25 Oct 2010to 10 Sep 2012
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight between 50 and 100 kg, both inclusive
- Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
- For haemophilia subjects only: Diagnosed with severe haemophilia A or B
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products
- Surgery planned to occur during the trial
- Any major and/or orthopaedic surgery within 30 days prior to trial product administration
Trial locations and contacts
16 sites in 11 countries.
16 sites in 11 countries
United Kingdom5 sites
Novo Nordisk Investigational Site
Harrow, HA1 3UJ
Novo Nordisk Investigational Site
London, NW3 2QG
Novo Nordisk Investigational Site
London, SE1 7EH
Novo Nordisk Investigational Site
London, W12 0NN
Novo Nordisk Investigational Site
Manchester, M13 9WL
Germany2 sites
Novo Nordisk Investigational Site
Berlin, 10249
Novo Nordisk Investigational Site
Frankfurt/M., 60590
South Africa1 site
Novo Nordisk Investigational Site
Polokwane, Limpopo, 0699
About this study
Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Being tested
- NNC 0172-0000-2021, placebo
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC 0172-0000-2021Drug
Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
NNC 0172-0000-2021Drug
Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.
placeboDrug
Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC 0172-0000-2021 |
| B | Experimental | Not described Receives: Drug: NNC 0172-0000-2021 |
| C | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
Measured: from trial product administration until 43 days after trial product administration
Secondary outcomes (2)
Area under the concentration-time curve
Measured: from 43 days after trial product administration until 53 days after trial product administration
Adverse Events (AEs), including Serious Adverse Events (SAEs)
Measured: from 43 days after trial product administration until 53 days after trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study start25 Oct 2010
- Primary completion10 Sep 2012
- Study completion10 Sep 2012
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 Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228669
- Sponsor's protocol ID
- NN7415-3813
- Other IDs
- 2010-020465-24, U1111-1116-2356
- Acronym
- Explorer 1
- Status last verified
- May 2019
- First submitted
- 25 Oct 2010
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chowdary P, Lethagen S, Friedrich U, Brand B, Hay C, Abdul Karim F, Klamroth R, Knoebl P, Laffan M, Mahlangu J, Miesbach W, Dalsgaard Nielsen J, Martin-Salces M, Angchaisuksiri P. Safety and pharmacokinetics of anti-TFPI antibody (concizumab) in healthy volunteers and patients with hemophilia: a randomized first human dose trial. J Thromb Haemost. 2015 May;13(5):743-54. doi: 10.1111/jth.12864. Epub 2015 Apr 6.
PubMed 25641556
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
- ClinicalTrials.gov ID
- NCT01228669
- Acronym / sponsor ID
- Explorer 1 / NN7415-3813
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2010 (actual)
- Primary completion
- 10 Sep 2012 (actual)
- Study completion
- 10 Sep 2012 (actual)
- First posted
- 26 Oct 2010 (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 trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NNC 0172-0000-2021 |
| B | Experimental | Drug: NNC 0172-0000-2021 |
| C | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body weight between 50 and 100 kg, both inclusive
- Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
- For haemophilia subjects only: Diagnosed with severe haemophilia A or B
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to trial product(s) or related products
- Surgery planned to occur during the trial
- Any major and/or orthopaedic surgery within 30 days prior to trial product 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 |
|---|---|---|
| NNC 0172-0000-2021Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose | Drug | A |
| NNC 0172-0000-2021Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose. | Drug | B |
| placeboSingle dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose. | Drug | C |
Primary outcome
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
Time frame: from trial product administration until 43 days after trial product administration
2 secondary outcomes
Area under the concentration-time curve
Time frame: from 43 days after trial product administration until 53 days after trial product administration
Adverse Events (AEs), including Serious Adverse Events (SAEs)
Time frame: from 43 days after trial product administration until 53 days after trial product administration
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 15 May 2019.
- Results publication: PubMed 25641556Chowdary P, Lethagen S, Friedrich U, Brand B, Hay C, Abdul Karim F, Klamroth R, Knoebl P, Laffan M, Mahlangu J, Miesbach W, Dalsgaard Nielsen J, Martin-Salces M, Angchaisuksiri P. Safety and pharmacokinetics of anti-TFPI antibody (concizumab) in healthy volunteers and patients with hemophilia: a randomized first human dose trial. J Thromb Haemost. 2015 May;13(5):743-54. doi: 10.1111/jth.12864. Epub 2015 Apr 6.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
16 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC 0172-0000-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 16 sites in 11 countries.
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 3 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 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, Germany, Austria, Denmark, Italy and 6 more countries. 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 of adverse Events (AEs), including Serious Adverse Events (SAEs) (time frame: from trial product administration until 43 days after trial product administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228669, 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 15 May 2019.