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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants with Frontotemporal Dementia
EU CTIS ID: 2023-508697-28-00
What this study is testing
Part A - To investigate the safety and tolerability of single doses of DNL593 in healthy participants Part B - To investigate the safety and tolerability of multiple doses of DNL593 in participants with FTD-GRN. Part C - To investigate the safety and tolerability of multiple doses of DNL593 in participants with FTD-GRN up to 18 months.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part A: - Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 55 years - BMI of ≥ 18 to ≤ 32 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 Part B: - Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 80 years. Women who are of childbearing potential but on highly effective, low user dependent contraceptive methods will be allowed. - BMI of ≥ 18 to ≤ 32 kg/m² - Have a Clinical Dementia Rating® plus National Alzheimer's Coordinating Center frontotemporal lobar degeneration global score ≥ 0.5 - Have confirmed granulin (GRN) mutation via genetic testing or historical records available for review by investigator - When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception Part C: All participants who completed Part B of this trial are eligible for an 18-month OLE if the participant has no unresolved clinically significant TEAEs, where continued dosing may represent a risk to participant safety.
You likely can't join if
- • Have any history of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders • Have a history of malignancy, except fully resected basal cell carcinoma or other malignancies at low risk of recurrence • Have a clinically significant history of stroke, cognitive impairment due to causes other than FTD, seizure within 5 years of screening, or head trauma with loss of consciousness within 2 years of screening • Have a positive serum pregnancy test or are currently lactating or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Turkey
- Colombia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Turkey; Colombia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.