A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- DNL919
- Conditions
- Healthy Participant
- Sponsor
- Denali Therapeutics Inc.
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.).
Investigators
Eligibility Criteria
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
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
Arms & Interventions
DNL919 (Healthy Participant)
Intervention: DNL919
Placebo (Healthy Participant)
Intervention: Placebo
Outcomes
Primary Outcomes
Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 45 days
Secondary Outcomes
- 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)