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

Phase 1

Completed

• Conditions: Healthy Participant
• Interventions: Drug: DNL919; Drug: Placebo

• Registration Number: NCT05450549
• Lead Sponsor: Denali Therapeutics Inc.

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.

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 Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-08
• Study Start: 2022-07-14
• Primary Completion: 2023-06-08
• Study Completion: 2023-06-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DNL919 (Healthy Participant)	DNL919	-
Placebo (Healthy Participant)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)	Up to 45 days

Secondary Outcome Measures

Name	Time	Method
PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf)	Up to 45 days
PK Parameter: Maximum concentration (Cmax) of DNL919 in serum	Up to 45 days

Trial Locations

Locations (1)

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