First in Human Study of NI-0701 in Healthy Volunteers

NCT01255501 | Completed Phase 1

• 1 other identifier: NI-0701-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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

Study Arms (2)

NI-0701

EXPERIMENTAL

Drug: NI-0701

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NI-0701 DRUG

NI-0701

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Light Chain Bioscience - Novimmune SA: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

Study Officials

• John Lambert, MD

  PXL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

GB (1)