First in Human Study of NI-0701 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255501
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
Information provided by:
NovImmune SA

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: NI-0701 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers

Arm Intervention/treatment
Experimental: NI-0701 Drug: NI-0701
Placebo Comparator: Placebo Drug: Placebo

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255501

United Kingdom
London, United Kingdom
Sponsors and Collaborators
NovImmune SA
Principal Investigator: John Lambert, MD PXL Identifier: NCT01255501     History of Changes
Other Study ID Numbers: NI-0701-01
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010