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

Sponsor
Denali Therapeutics Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05450549
Collaborator
Takeda (Industry)
80
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DNL919 (Healthy Participant)

Drug: DNL919
Single doses
Placebo Comparator: Placebo (Healthy Participant)

Drug: Placebo
Single doses

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. PK Parameter: Maximum concentration (Cmax) of DNL919 in serum [Up to 45 days]

  2. PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf) [Up to 45 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Denali Therapeutics Inc.
  • Takeda

Investigators

  • Study Director: Ana-Claire Meyer, MD, Denali Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Denali Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT05450549
Other Study ID Numbers:
  • DNLI-G-0001
  • 2022-000756-10
First Posted:
Jul 8, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jul 8, 2022