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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05450549
Recruitment Status : Recruiting
First Posted : July 8, 2022
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Denali Therapeutics Inc.

Study Description
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Brief Summary:
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.

Condition or disease Intervention/treatment Phase
Healthy Participant Drug: DNL919 Drug: Placebo Phase 1

Detailed Description:
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Actual Study Start Date : July 14, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: DNL919 (Healthy Participant) Drug: DNL919
Single doses
Placebo Comparator: Placebo (Healthy Participant) Drug: Placebo
Single doses


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 45 days ]

Secondary Outcome Measures :
  1. PK Parameter: Maximum concentration (Cmax) of DNL919 in serum [ Time Frame: Up to 45 days ]
  2. PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: Up to 45 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive
  • BMI 18.5 to <30 kg/m²
  • When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception

Key Exclusion Criteria:

  • History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
  • History of malignancy
  • History of clinically significant stroke
  • History of cognitive impairment
  • Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05450549


Locations
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Netherlands
Centre for Human Drug Research (CHDR) Recruiting
Leiden, South Holland, Netherlands, 2333
Contact: Project Manager    +31 71 5246 400    clintrials@chdr.nl   
Principal Investigator: Philip Kremer, MD, PhD         
Sponsors and Collaborators
Denali Therapeutics Inc.
Takeda
Investigators
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Study Director: Ana-Claire Meyer, MD Denali Therapeutics Inc.
More Information
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Responsible Party: Denali Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05450549    
Other Study ID Numbers: DNLI-G-0001
2022-000756-10 ( EudraCT Number )
First Posted: July 8, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No