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CompletedNCT04551534Updated Sep 16, 2020

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

A Phase 1 interventional study of DNL201 and Placebo in Healthy Volunteers, sponsored by Denali Therapeutics Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Denali Therapeutics Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2018, 8 years 2 months ago, and no results have been posted to the registry.
  • Registered 3 years 3 months after the study started (first participant enrolled Jun 2017, registered Sep 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Denali Therapeutics Inc. is the lead sponsor of 19 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening
  • In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements
  • Women of non-childbearing potential and men using contraceptive measures

Key Exclusion Criteria:

  • History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders
  • History of asthma, chronic obstructive pulmonary disease, or emphysema
  • Clinically significant neurologic disorder
  • History of stomach or intestinal surgery or resection
  • History of malignancy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    DNL201

    Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)

    Drug: DNL201

  • Placebo comparator
    Placebo

    Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)

    Drug: Placebo

Interventions

  • DrugDNL201

    Oral dose(s)

  • DrugPlacebo

    Oral dose(s)

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs

    Time frame: Up to 20 days

  2. PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma

    Time frame: Up to 10 days

  3. PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma

    Time frame: Up to 10 days

  4. PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)

    Time frame: Up to 10 days

  5. PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma

    Time frame: Up to 10 days

  6. PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)

    Time frame: Up to 10 days

  7. PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma

    Time frame: Up to 10 days

Secondary outcomes

  1. Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)

    Time frame: Up to 10 days

  2. The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935

    Time frame: Up to 10 days

07

Study locations

1 site
  • Clinical Site(s)
    Dallas, Texas 05247, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04551534
Lead sponsor
Denali Therapeutics Inc.
Responsible party
Sponsor
First posted
Sep 16, 2020
Start date
Jun 1, 2017
Primary completion
Aug 8, 2018
Completion
Aug 8, 2018
Last update
Sep 16, 2020

Study contacts

Danna Jennings, MD
study director · Denali Therapeutics Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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