FindTrial
Sign In

First in Human Study of NI-0701 in Healthy Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01255501
Enrollment
Unknown
Registered
2010-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGNI-0701
DRUGPlacebo

Sponsors

Light Chain Bioscience - Novimmune SA
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026