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

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Denali Therapeutics

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: DNL201
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04551534
DNLI-B-0001

Details and patient eligibility

About

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

Enrollment

122 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

122 participants in 2 patient groups, including a placebo group

DNL201
Experimental group
Description:
Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)
Treatment:
Drug: DNL201
Placebo
Placebo Comparator group
Description:
Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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