NL-OMON56265
Recruiting
Not Applicable
A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants with Amyotrophic Lateral Sclerosis - DNL343 in participants with ALS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Denali Therapeutics Inc
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must satisfy all of the following criteria for study entry:
- •1\. Women of non\-childbearing potential and men, aged 18 to 80 years, inclusive
- •2\. BMI of 18 to 35 kg/m2
- •3\. Willing and able to give informed consent (via legally authorized
- •representative is acceptable) for study participation
- •4\. Able to communicate with the investigator and staff
- •5\. Willing and able to comply with the requirements of the study, including
- •scheduled visits, study restrictions, laboratory tests, and all other study
- •6\. Women must have been surgically sterilized (hysterectomy, bilateral
- •oophorectomy, or bilateral tubal ligation; proper documentation required) \>\= 3
Exclusion Criteria
- •Participants who meet any of the following criteria will be excluded from study
- •1\. Any history of unstable or poorly controlled psychiatric, endocrine,
- •pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal,
- •metabolic, hematologic, immunologic, or allergic disease, or other major
- •disorders. Well\-controlled conditions are permitted if investigator and Sponsor
- •2\. Positive serum pregnancy test or currently lactating or breastfeeding
- •3\. History of malignancy within 5 years, except fully resected basal cell
- •carcinoma or other malignancies at low risk of recurrence, depending on
- •investigator and Medical Monitor agreement
- •4\. History of clinically significant neurologic disorders other than ALS,
Outcomes
Primary Outcomes
Not specified
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