Safety and Tolerability of PNT001 in Healthy Adults
This Phase I clinical trial will evaluate the safety and tolerability of PNT001 in healthy adults. PNT001 is an antibody designed to stop the spread of a specific form of abnormal tau, a protein that forms harmful neurofibrillary tangles in the brains of people with Alzheimer's disease. These tangles contribute to impaired memory and learning.
|Minimum Age||Maximum Age||Gender||Healthy Volunteers|
|21 Years||65 Years||All||Yes|
- Female participants must not be of childbearing potential or currently breastfeeding
- Male participants must agree to use barrier contraceptives plus spermicide and refrain from sperm donation during the entire study and for 200 days after dosing has been completed
- No participation in a clinical drug trial within 3 months of study start
- Body mass index of 18.5 to 30
- Inability to undergo lumbar puncture
- Any significant acute or chronic medical illness
- History of cancer within 5 years of enrollment, with the exception of resected skin basal cell carcinoma
- Major surgery within 4 weeks of study drug administration
- Donation of blood or serum to a blood bank or in a clinical study within 3 months of study drug administration
- Inability to undergo venipuncture or tolerate venous access
- History of smoking or using tobacco products within 3 months before study drug administration
- History of drug or alcohol abuse
- Evidence of clinically significant neurological or psychiatric disorder that could interfere with study assessments; history or current status of schizophrenia, schizoaffective disorder, bipolar disorder, or untreated major depression; potential suicide risk
- Any of the following abnormalities: serum creatinine >1.5 mg/dL at screening; AST or ALT >2x the upper limit of normal at screening; blood pressure >140/90 Hg at screening or baseline; QTcF 470 msec at screening or baseline
- Known hypersensitivity to any components of the PNT001 drug product or placebo (5% dextrose)
Participants will be randomly assigned to take either the experimental study drug or a placebo, given intravenously for 30-60 minutes. Five different doses will be tested. Participants will stay overnight at the study site for 4 days and will return for an outpatient visit on Day 5 (in person or by phone) and on Days 7, 14, 28, 42, 56, 70, 84, 98, and 112. Researchers will assess the drug's safety, tolerability, and other data over 16 weeks.
Woodland Research Northwest
Pacific Research Network, Inc.
Hassman Research Institute
Worldwide Clinical Trials
Pinteon Therapeutics, Inc.
|Larry D. Altstiel, MD, PhD||Study Director||Pinteon Therapeutics, Inc.|
|Wendy J. Lucaemail@example.com|
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Intravenous PNT001 in Healthy Volunteers