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OpenTrials
Completed

NCT Number: NCT01255501

First in Human Study 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NI-0701

Drug

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

Light Chain Bioscience - Novimmune SA

Industry

Registry information

Official study title

A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers

Important dates

First posted
Dec 7, 2010
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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