NCT04551534 is a Phase 1 clinical trial of DNL201 in Healthy Volunteers, sponsored by Denali Therapeutics Inc..

Who is sponsoring NCT04551534?

NCT04551534 is sponsored by Denali Therapeutics Inc..

What drugs are being tested in NCT04551534?

Interventions in NCT04551534: DNL201, Placebo.

What condition does NCT04551534 study?

NCT04551534 studies Healthy Volunteers.

Is NCT04551534 still recruiting?

NCT04551534 is currently completed. Last updated 16 September 2020.

Last reviewed 2020-09-16 · How we verify

NCT04551534

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers

Completed Phase 1 Last updated 16 September 2020

What this trial tests

Phase 1 trial testing DNL201 in Healthy Volunteers in 122 participants. Completed in 8 August 2018.

Timeline

1 June 2017

Primary endpoint
8 August 2018

8 August 2018

Quick facts

Lead sponsor	Denali Therapeutics Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	122
Start date	1 June 2017
Primary completion	8 August 2018
Estimated completion	8 August 2018
Sites	1 location across United States

Drugs / interventions tested

DNL201 — full drug profile →
Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Denali Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.

Publications & conference data

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

Perspective on the current state of the LRRK2 field.
Taymans JM, Fell M, Greenamyre T, Hirst WD, et al · · 2023 · cited 96× · PMID 37393318 · DOI 10.1038/s41531-023-00544-7
Therapeutics in the Pipeline Targeting <i>α</i>-Synuclein for Parkinson's Disease.
Grosso Jasutkar H, Oh SE, Mouradian MM. · · 2022 · cited 69× · PMID 35017177 · DOI 10.1124/pharmrev.120.000133
Lipids as Emerging Biomarkers in Neurodegenerative Diseases.
Wei J, Wong LC, Boland S. · · 2023 · cited 46× · PMID 38203300 · DOI 10.3390/ijms25010131
Genotype-driven therapeutic developments in Parkinson's disease.
Prasuhn J, Brüggemann N. · · 2021 · cited 32× · PMID 33874883 · DOI 10.1186/s10020-021-00281-8
The emerging role of LRRK2 in tauopathies.
Herbst S, Lewis PA, Morris HR. · · 2022 · cited 20× · PMID 35815712 · DOI 10.1042/cs20220067
Lysosomal dysfunction in α-synuclein pathology: molecular mechanisms and therapeutic strategies.
Dai L, Liu M, Ke W, Chen L, et al · · 2024 · cited 17× · PMID 39223418 · DOI 10.1007/s00018-024-05419-5
α-Synuclein in Parkinson's Disease: From Bench to Bedside.
Bellini G, D'Antongiovanni V, Palermo G, Antonioli L, et al · · 2025 · cited 14× · PMID 39704040 · DOI 10.1002/med.22091
Precision Medicine in Parkinson's Disease: From Genetic Risk Signals to Personalized Therapy.
Straccia G, Colucci F, Eleopra R, Cilia R. · · 2022 · cited 9× · PMID 36291241 · DOI 10.3390/brainsci12101308

Verify or expand the search:

Other trials of DNL201

Trials testing the same drug.

NCT03710707 — Study to Evaluate DNL201 in Subjects With Parkinson's Disease · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Denali Therapeutics Inc. trials

Trials by the same sponsor.

NCT06602193 — Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) · Phase 2 · recruiting
NCT06281158 — A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in · Phase 1 · completed
NCT05450549 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants · Phase 1 · completed
NCT05006352 — A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Later · Phase 1 · completed
NCT04581772 — A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04551534 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Denali Therapeutics Inc.
Last refreshed: 16 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04551534.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing