Skip to main content

Safety and Tolerability of PNT001 in Healthy Adults

Recruiting

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
September 17, 2019
November 2020
48

  • 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.

 

Name City State Zip Status Primary Contact
Woodland Research Northwest
Rogers Arkansas 72758 Recruiting Petra Stark
479-927-3000
pstark@ergclinical.com
Pacific Research Network, Inc.
San Diego California 92103 Recruiting Dixie Creager
619-294-4302
dcreager@ergclinical.com
Hassman Research Institute
Marlton New Jersey 08053 Recruiting Lisa Wilkins
856-753-7335
lwilkins@hritrials.com
Worldwide Clinical Trials
San Antonio Texas 78217 Recruiting Debbie Miksch
512-615-2285
debbie.miksch@worldwide.com

Pinteon Therapeutics, Inc.

Name Role Affiliation
Larry D. Altstiel, MD, PhD Study Director Pinteon Therapeutics, Inc.

Name Phone Email
Wendy J. Luca 860-319-9938 wluca@pinteon.com

NCT04096287

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