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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014