A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

• Status: Completed
• Trial end date: 2019-10-10
• Target enrollment: 0
• Participant gender: All

Summary

This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neurop Inc.
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Pharmaron

Criteria

Inclusion Criteria:

• Male and female subjects aged 18 to 55 years

• Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.

• If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.

Exclusion Criteria:

• Clinical laboratory values greater than or equal to 2 times the upper limit of normal.

• Recent history (within 2 yrs) or current tobacco use.