A Phase 1 interventional study of DNL343 and Placebo in Healthy Volunteers, sponsored by Denali Therapeutics Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-07.
Sponsored by Denali Therapeutics Inc. · Phase 1, Interventional, and Treatment
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.
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.).
Denali Therapeutics Inc. is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses
Drug: DNL343
Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses
Drug: Placebo
Single and repeating oral dose(s)
Single and repeating oral dose(s)
Incidence and severity of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs
Time frame: Up to 20 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Time frame: Up to 20 days
PK parameter: The area under the concentration-time curve from zero to 12 or 24 hours for twice daily (BID) or once daily (QD) dosing, respectively (AUC0-τ) of DNL343 in plasma
Time frame: Up to 20 days
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma
Time frame: Up to 20 days
PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL343 in plasma
Time frame: Up to 20 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma
Time frame: Up to 20 days
PK parameter: Apparent terminal elimination rate constant (λz) with the respective t½ of DNL343 in plasma
Time frame: Up to 20 days
PK parameter: The amount of DNL343 excreted in urine from time zero to 48 hours postdose (Ae48)
Time frame: Up to 20 days
PK parameter: Estimation of renal clearance (CLR)
Time frame: Up to 20 days
PK parameter: Concentration of DNL343 in cerebrospinal fluid (CSF)
Time frame: Up to 20 days
The PD of DNL343 in blood as measured by percent reduction of integrated stress response (ISR) protein levels measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Up to 20 days
The PD of DNL343 in blood as measured by percent reduction in ISR gene expression levels measured by quantitative polymerase chain reaction (qPCR)
Time frame: Up to 20 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Denali Therapeutics Inc.