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CompletedNCT01255501Updated Dec 7, 2010

First in Human Study of NI-0701 in Healthy Volunteers

A Phase 1 interventional study of NI-0701 and Placebo in Healthy Volunteers, sponsored by Light Chain Bioscience - Novimmune SA. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-07.

Sponsored by Light Chain Bioscience - Novimmune SA · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Light Chain Bioscience - Novimmune SA is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Non smokers
  • Able to adhere to study visits and protocol requirements

Exclusion criteria

Exclusion Criteria:

  • Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale
  • Established or recurrent history of allergic reactions
05

Study design

Phase
Phase 1

Study arms

  • Experimental
    NI-0701

    Drug: NI-0701

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugNI-0701
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers

Secondary outcomes

  1. NI-0701 Pharmacokinetic parameters in healthy volunteers

  2. NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion

  3. Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare

  4. Immunogenicity of NI-0701

07

Study locations

1 site
  • London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01255501
Lead sponsor
Light Chain Bioscience - Novimmune SA
First posted
Dec 7, 2010
Last update
Dec 7, 2010

Study contacts

John Lambert, MD
principal investigator · PXL
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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