First in Human Study of NI-0701 in Healthy Volunteers

Light Chain Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NI-0701; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01255501

NI-0701-01

Details and patient eligibility

About

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

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

NI-0701

Experimental group

Treatment:

Drug: NI-0701

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo