NCT03838185

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

Completed Phase 1 Last updated 3 September 2020

What this trial tests

Phase 1 trial testing J147 in Alzheimer's Disease in 64 participants. Completed in 1 February 2020.

Timeline

22 January 2019

Primary endpoint
1 February 2020

1 February 2020

Quick facts

Lead sponsor	Abrexa Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	22 January 2019
Primary completion	1 February 2020
Estimated completion	1 February 2020
Sites	1 location across United States

Drugs / interventions tested

• J147 — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Abrexa Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. The study will include single ascending dose (SAD) in healthy young and elderly subjects.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2019.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
2. Alzheimer's disease drug development pipeline: 2020.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
3. CMS121, a fatty acid synthase inhibitor, protects against excess lipid peroxidation and inflammation and alleviates cognitive loss in a transgenic mouse model of Alzheimer's disease.
   Ates G, Goldberg J, Currais A, Maher P. · · 2020 · cited 115× · PMID 32863221 · DOI 10.1016/j.redox.2020.101648
4. Using the Oxytosis/Ferroptosis Pathway to Understand and Treat Age-Associated Neurodegenerative Diseases.
   Maher P, Currais A, Schubert D. · · 2020 · cited 88× · PMID 33176157 · DOI 10.1016/j.chembiol.2020.10.010
5. Targeting whole body metabolism and mitochondrial bioenergetics in the drug development for Alzheimer's disease.
   Austad SN, Ballinger S, Buford TW, Carter CS, et al · · 2022 · cited 66× · PMID 35256932 · DOI 10.1016/j.apsb.2021.06.014
6. Natural products targeting mitochondria: emerging therapeutics for age-associated neurological disorders.
   Liang Z, Currais A, Soriano-Castell D, Schubert D, et al · · 2021 · cited 53× · PMID 33227325 · DOI 10.1016/j.pharmthera.2020.107749
7. Diabetes and Alzheimer's Disease: Might Mitochondrial Dysfunction Help Deciphering the Common Path?
   Potenza MA, Sgarra L, Desantis V, Nacci C, et al · · 2021 · cited 47× · PMID 34439505 · DOI 10.3390/antiox10081257
8. Closest horizons of Hsp70 engagement to manage neurodegeneration.
   Venediktov AA, Bushueva OY, Kudryavtseva VA, Kuzmin EA, et al · · 2023 · cited 25× · PMID 37795273 · DOI 10.3389/fnmol.2023.1230436