NCT03672604

A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects

A Phase 1, Single- and Multiple-Dose, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of NLY01 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Neuraly, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is intended to identify the appropriate dose-range for evaluation in Parkinson's disease patients.

Detailed description

This is a Phase 1, first-in-human, double-blind, randomized, placebo-controlled, single and multiple-dose study to assess the safety, tolerability, and PK of NLY01, a PEGylated form of the anti-diabetic peptide exenatide, when administered by SC injection in healthy subjects. In Part A of the study, 5 ascending-dose cohorts will be sequentially enrolled with an evaluation of safety and tolerability prior to each dose-escalation. Subjects in each cohort will be randomized to receive NLY01 or placebo. Each dose escalation and selection of doses for Part B will be conducted with oversight by an independently-chaired Safety Review Committee. In Part B, subjects will receive once-weekly subcutaneous doses of NLY01 or placebo for 4 weeks. Three ascending-dose cohorts will be sequentially-enrolled with a safety review prior to each dose-escalation. Subjects in all Part B cohorts will receive fixed doses of NLY01 (or placebo) once-weekly for 4 weeks.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	NLY01	NLY01, a PEGylated form of the anti-diabetic peptide exenatide

Timeline

• Start date: 2018-09-19
• Primary completion: 2019-07-30
• Completion: 2019-07-30
• First posted: 2018-09-14
• Last updated: 2019-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study