HealthyPhase 1ATN-103NCT00916110
Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects
A Phase 1 study testing ATN-103 in people with Healthy, run by Ablynx, a Sanofi company at 1 site in Japan.
Trial summary
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ATN-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2008to Nov 2009
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
- BMI in the range of 17.6 to 26.4.
- Nonsmoker or male who smokes fewer than 10 cigarettes per day.
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
- Conditions
- Healthy
- Being tested
- ATN-103
- Keywords
- healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-103Drug
1.5 mg solution, single subcutaneous injection
ATN-103Drug
4 mg solution, single subcutaneous injection
ATN-103Drug
10 mg solution, single subcutaneous injection
ATN-103Drug
25 mg solution, single subcutaneous injection
ATN-103Drug
25 mg solution, single intravenous injection
ATN-103Drug
50 mg solution, single subcutaneous injection
ATN-103Drug
100 mg solution, single subcutaneous injection
ATN-103Drug
200 mg solution, single subcutaneous injection
ATN-103Drug
200 mg solution, single intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 1.5mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 4mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 10mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 25mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 25mgIV | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 50mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 100mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 200mgSC | Experimental | ATN-103 Receives: Drug: ATN-103 |
| 200mgIV | Experimental | ATN-103 Receives: Drug: ATN-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
Measured: 24weeks
Secondary outcomes (1)
Antibody in blood and drug concentration in blood and urine are evaluated.
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josefin-Beate Holz, MD, Study director, Ablynx NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916110
- Sponsor's protocol ID
- 3242K1-1001
- Other IDs
- B2271002
- Acronym
- ATN-103
- Status last verified
- Jan 2013
- First submitted
- 28 May 2009
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT00916110
- Acronym / sponsor ID
- ATN-103 / 3242K1-1001
- Conditions
- Healthy
- Keywords
- healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Jun 2009 (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.
To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1.5mgSC | Experimental | Drug: ATN-103ATN-103 |
| 4mgSC | Experimental | Drug: ATN-103ATN-103 |
| 10mgSC | Experimental | Drug: ATN-103ATN-103 |
| 25mgSC | Experimental | Drug: ATN-103ATN-103 |
| 25mgIV | Experimental | Drug: ATN-103ATN-103 |
| 50mgSC | Experimental | Drug: ATN-103ATN-103 |
| 100mgSC | Experimental | Drug: ATN-103ATN-103 |
| 200mgSC | Experimental | Drug: ATN-103ATN-103 |
| 200mgIV | Experimental | Drug: ATN-103ATN-103 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
- BMI in the range of 17.6 to 26.4.
- Nonsmoker or male who smokes fewer than 10 cigarettes per day.
Key exclusion criteria (2 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.
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 |
|---|---|---|
| ATN-1031.5 mg solution, single subcutaneous injection | Drug | 1.5mgSC |
| ATN-1034 mg solution, single subcutaneous injection | Drug | 4mgSC |
| ATN-10310 mg solution, single subcutaneous injection | Drug | 10mgSC |
| ATN-10325 mg solution, single subcutaneous injection | Drug | 25mgSC |
| ATN-10325 mg solution, single intravenous injection | Drug | 25mgIV |
| ATN-10350 mg solution, single subcutaneous injection | Drug | 50mgSC |
| ATN-103100 mg solution, single subcutaneous injection | Drug | 100mgSC |
| ATN-103200 mg solution, single subcutaneous injection | Drug | 200mgSC |
| ATN-103200 mg solution, single intravenous injection | Drug | 200mgIV |
Primary outcome
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
Time frame: 24weeks
1 secondary outcome
Antibody in blood and drug concentration in blood and urine are evaluated.
Time frame: 24weeks
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 16 Jan 2013.
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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.
Josefin-Beate Holz, MD study director
Ablynx NV
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 ATN-103 in people with Healthy, run by Ablynx, a Sanofi company at 1 site in Japan.
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 2 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 16 Jan 2013. 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 Japan. 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?
Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc. (time frame: 24weeks). 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 16 Jan 2013.