Healthy Subjects and Atopic Dermatitis SubjectsPhase 1NCT01614756
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
A Phase 1 study testing BMS-981164 in people with Healthy Subjects and Atopic Dermatitis Subjects, run by Bristol-Myers Squibb at 4 sites in United Kingdom.
Trial summary
The purpose of the study is to determine safety and tolerability of IL-31 mAB Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects and Atopic Dermatitis Subjects
- What is being tested?
- BMS-981164
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2012to Apr 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1: Healthy subjects
- Part 2: Adult subjects with:
- Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5
- Pruritus severity of at least 7 of 10 on a visual analog scale
Who cannot join
- Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Local Institution
Manchester, Greater Manchester, M15 6SH
Local Institution
Manchester, M6 8HD
Local Institution
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Local Institution
Nottingham, NG11 6JS
About this study
Official title: A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis
The purpose of the study is to determine safety and tolerability of IL-31 mAB
Read the detailed description
Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)
Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis
- Being tested
- BMS-981164, Placebo matching with BMS-981164
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-981164Biological
Also called IL-31 mAB
Placebo matching with BMS-981164Biological
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo | Experimental | Part 1
Single dose of BMS-981164 0.1 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo | Experimental | Part 1
Single dose of BMS-981164 0.01 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo | Experimental | Part 1
Single dose of BMS-981164 0.03 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo | Experimental | Part 1
Single dose of BMS-981164 0.06 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo | Experimental | Part 1
Single dose of BMS-981164 0.1 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo | Experimental | Part 1
Single dose of BMS-981164 0.3 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo | Experimental | Part 1
Single dose of BMS-981164 1 mg/kg solution subcutaneously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo | Experimental | Part 1
Single dose of BMS-981164 1 mg/kg solution intravenously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo | Experimental | Part 1
Single dose of BMS-981164 3 mg/kg solution intravenously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo | Experimental | Part 1
Single dose of BMS-981164 10.0 mg/kg solution intravenously
OR
Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation- BMS-981164 or Placebo (dose group 1) | Experimental | Part 2
BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose
OR
Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation- BMS-981164 or Placebo (dose group 2) | Experimental | Part 2
BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose
OR
Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation- BMS-981164 or Placebo (dose group 3) | Experimental | Part 2
BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose
OR
Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
| Dose Escalation- BMS-981164 or Placebo (dose group 4) | Experimental | Part 2
BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and >1.0mg/kg, once, single dose
OR
Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose Receives: Biological: BMS-981164; Biological: Placebo matching with BMS-981164 |
What is being measured
The primary outcome is the main question the study is designed to answer.
For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests
Measured: Up to 16 weeks after single dose
Secondary outcomes (11)
The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Area under the serum concentration-time curve from zero to time of the last quantifiable concentration [AUC(0-T)] of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time
Measured: 13 timepoints upto 16 weeks after single dose
Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments
The Immunogenicity of BMS-981164 will be assessed by this ADA assessments
Measured: Up to 16 weeks after single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects and Atopic Dermatitis SubjectsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614756
- Sponsor's protocol ID
- IM134-002
- Other IDs
- 2012-001865-34
- Status last verified
- Aug 2015
- First submitted
- 6 Jun 2012
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01614756
- Acronym / sponsor ID
- IM134-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jun 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 the study is to determine safety and tolerability of IL-31 mAB
Detailed description
Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)
Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 0.01 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 0.03 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 0.06 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 0.3 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 1 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
| Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 3 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
| Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 1 Single dose of BMS-981164 10.0 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
| Dose Escalation- BMS-981164 or Placebo (dose group 1) | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose |
| Dose Escalation- BMS-981164 or Placebo (dose group 2) | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
| Dose Escalation- BMS-981164 or Placebo (dose group 3) | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
| Dose Escalation- BMS-981164 or Placebo (dose group 4) | Experimental | Biological: BMS-981164, Biological: Placebo matching with BMS-981164Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and >1.0mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Part 1: Healthy subjects
- Part 2: Adult subjects with:
Key exclusion criteria (1 listed)
- Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study 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 |
|---|---|---|
| BMS-981164Also: IL-31 mAB | Biological | Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo, Dose Escalation- BMS-981164 or Placebo (dose group 1), Dose Escalation- BMS-981164 or Placebo (dose group 2), Dose Escalation- BMS-981164 or Placebo (dose group 3), Dose Escalation- BMS-981164 or Placebo (dose group 4), Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo, Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo, Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo, Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo, Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo |
| Placebo matching with BMS-981164 | Biological | Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo, Dose Escalation- BMS-981164 or Placebo (dose group 1), Dose Escalation- BMS-981164 or Placebo (dose group 2), Dose Escalation- BMS-981164 or Placebo (dose group 3), Dose Escalation- BMS-981164 or Placebo (dose group 4), Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo, Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo, Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo, Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo, Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo, Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo |
Primary outcome
For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests
Time frame: Up to 16 weeks after single dose
11 secondary outcomes
The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Area under the serum concentration-time curve from zero to time of the last quantifiable concentration [AUC(0-T)] of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time
Time frame: 13 timepoints upto 16 weeks after single dose
Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments
Time frame: Up to 16 weeks after single dose
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 19 Aug 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-981164 in people with Healthy Subjects and Atopic Dermatitis Subjects, run by Bristol-Myers Squibb at 4 sites in United Kingdom.
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 4 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests (time frame: Up to 16 weeks after single dose). 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 19 Aug 2015.