Healthy VolunteersPhase 1NCT04551534
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers
A Phase 1 study testing DNL201 in people with Healthy Volunteers, run by Denali Therapeutics Inc. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DNL201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 8 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of DNL201 in Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.
- Conditions
- Healthy Volunteers
- Being tested
- DNL201, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNL201Drug
Oral dose(s)
PlaceboDrug
Oral dose(s)
| Study group | Role | What they receive |
|---|---|---|
| DNL201 | Experimental | Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) Receives: Drug: DNL201 |
| Placebo | Placebo comparator | Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs
Measured: Up to 20 days
PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma
Measured: Up to 10 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma
Measured: Up to 10 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)
Measured: Up to 10 days
PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma
Measured: Up to 10 days
PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)
Measured: Up to 10 days
PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma
Measured: Up to 10 days
Secondary outcomes (2)
Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)
Measured: Up to 10 days
The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Jun 2017
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denali Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danna Jennings, MD, Study director, Denali Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551534
- Sponsor's protocol ID
- DNLI-B-0001
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
PubMed 40680102
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of DNL201 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04551534
- Acronym / sponsor ID
- DNLI-B-0001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Denali Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNL201 | Experimental | Drug: DNL201Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) |
| Placebo | Placebo comparator | Drug: PlaceboPart 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNL201Oral dose(s) | Drug | DNL201 |
| PlaceboOral dose(s) | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs
Time frame: Up to 20 days
PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma
Time frame: Up to 10 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma
Time frame: Up to 10 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)
Time frame: Up to 10 days
PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma
Time frame: Up to 10 days
PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)
Time frame: Up to 10 days
PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma
Time frame: Up to 10 days
2 secondary outcomes
Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)
Time frame: Up to 10 days
The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 40680102Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danna Jennings, MD study director
Denali Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNL201 in people with Healthy Volunteers, run by Denali Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs (time frame: Up to 20 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.