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First in Human Study of NI-0701 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
NovImmune SA
ClinicalTrials.gov Identifier:
NCT01255501
First received: December 6, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 Intervention Phase
Healthy Volunteers
 Drug: NI-0701
Drug: Placebo
 Phase 1

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

Further study details as provided by NovImmune SA:

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

Secondary Outcome Measures:
  • 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

Arms Assigned Interventions
Experimental: NI-0701 Drug: NI-0701
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255501

Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
NovImmune SA
Investigators
Principal Investigator: John Lambert, MD PXL
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01255501     History of Changes
Other Study ID Numbers: NI-0701-01
Study First Received: December 6, 2010
Last Updated: December 6, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on June 18, 2013