MedPath

DNL343

Generic Name
DNL343
Drug Type
Small Molecule
CAS Number
2278265-85-1
Background

DNL343 is under investigation in clinical trial NCT05842941 (HEALEY ALS Platform Trial - Regimen G DNL343).

HEALEY ALS Platform Trial - Regimen G DNL343

Phase 2
Completed
Conditions
Amyotrophic Lateral Sclerosis
Interventions
Drug: Matching Placebo
First Posted Date
2023-05-06
Last Posted Date
2025-02-04
Lead Sponsor
Merit E. Cudkowicz, MD
Target Recruit Count
249
Registration Number
NCT05842941
Locations
🇺🇸

Healey Center for ALS at Massachusetts General Hospital, Boston, Massachusetts, United States

A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

Phase 1
Active, not recruiting
Conditions
Amyotrophic Lateral Sclerosis
Interventions
Drug: Placebo
First Posted Date
2021-08-16
Last Posted Date
2023-01-17
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
30
Registration Number
NCT05006352
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

Atrium Health Neurosciences Institute, Charlotte, North Carolina, United States

🇺🇸

PPD Orlando, Orlando, Florida, United States

and more 4 locations

A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2020-10-09
Last Posted Date
2021-06-11
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
31
Registration Number
NCT04581772
Locations
🇳🇿

Auckland Clinical Studies Ltd., Grafton, Auckland, New Zealand

HEALEY ALS Platform Trial - Master Protocol

Phase 2
Active, not recruiting
Conditions
Amyotrophic Lateral Sclerosis
Interventions
First Posted Date
2020-03-05
Last Posted Date
2024-12-30
Lead Sponsor
Merit E. Cudkowicz, MD
Target Recruit Count
1500
Registration Number
NCT04297683
Locations
🇺🇸

Neurology Associates, P.C./Somnos Clinical Research, Lincoln, Nebraska, United States

🇺🇸

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

and more 73 locations

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2020-02-13
Last Posted Date
2022-02-07
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
96
Registration Number
NCT04268784
Locations
🇳🇱

Centre for Human Drug Research (CHDR), Leiden, South Holland, Netherlands

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