NCT03838185

Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147 in Healthy Young Volunteers and Healthy Elderly Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Abrexa Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects.

Detailed description

This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects and to perform a preliminary assessment of the effect of food on safety and PK parameters of J147. The study will include single ascending dose (SAD) in healthy young and elderly subjects. Approximately 64 subjects may be included in the study, with an additional 24 to be added depending on the emerging data. Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and female subjects are planned. Depending on emerging safety, tolerability and PK data, 2 additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of 8 elderly male and female subjects may be enrolled. In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2 subjects will be randomized to receive a matching dose of placebo. All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1 subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours following the sentinel subjects. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	J147	Single oral dose of J147
DRUG	Placebo	Single oral dose of corn oil

Timeline

• Start date: 2019-01-22
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-02-12
• Last updated: 2020-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study