Healthy VolunteersPhase 1NCT01255501
First in Human Study of NI-0701 in Healthy Volunteers
A Phase 1 study testing NI-0701 in people with Healthy Volunteers, run by Light Chain Bioscience - Novimmune SA at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NI-0701
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non smokers
- Able to adhere to study visits and protocol requirements
Who cannot join
- Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale
- Established or recurrent history of allergic reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- NI-0701, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NI-0701Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NI-0701 | Experimental | Not described Receives: Drug: NI-0701 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers
Secondary outcomes (4)
NI-0701 Pharmacokinetic parameters in healthy volunteers
NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion
Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare
Immunogenicity of NI-0701
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
Sponsor and investigators
- Lead sponsor
- Light Chain Bioscience - Novimmune SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Lambert, MD, Principal investigator, PXL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255501
- Sponsor's protocol ID
- NI-0701-01
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01255501
- Acronym / sponsor ID
- NI-0701-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Light Chain Bioscience - Novimmune SAIndustry (pharma, biotech, devices)
- First posted
- 7 Dec 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.
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NI-0701 | Experimental | Drug: NI-0701 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non smokers
- Able to adhere to study visits and protocol requirements
Key exclusion criteria (2 listed)
- Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale
- Established or recurrent history of allergic reactions
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 |
|---|---|---|
| NI-0701 | Drug | NI-0701 |
| Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers
4 secondary outcomes
NI-0701 Pharmacokinetic parameters in healthy volunteers
NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion
Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare
Immunogenicity of NI-0701
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 Dec 2010.
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Screening Protocol
Pain
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.
John Lambert, MD principal investigator
PXL
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 NI-0701 in people with Healthy Volunteers, run by Light Chain Bioscience - Novimmune SA at 1 site 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 2 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 7 Dec 2010. 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 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. 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?
Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers. 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 7 Dec 2010.