First in Human Study of NI-0701 in Healthy Volunteers

Light Chain Bioscience - Novimmune SA

Overview

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

Interventions

NI-0701DRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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