A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2021-08-03

Brief Summary

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This is a Phase 1 study carried out at a single site in 88 healthy male subjects and healthy female subjects of non childbearing potential to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of DNL343.

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Detailed Description

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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.).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DNL343

Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses

Group Type EXPERIMENTAL

DNL343

Intervention Type DRUG

Single and repeating oral dose(s)

Placebo

Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single and repeating oral dose(s)

Interventions

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DNL343

Single and repeating oral dose(s)

Intervention Type DRUG

Placebo

Single and repeating oral dose(s)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women of non-childbearing potential and men; aged 18-50 years, inclusive
* BMI 18-32 kg/m², inclusive, and body weight of at least 50 kg

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes