Status:
COMPLETED
Safety and Tolerability of PNT001 in Healthy Adults
Lead Sponsor:
Pinteon Therapeutics, Inc
Conditions:
Healthy
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
This first in human study is a multi-center, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intr...
Detailed Description
This Phase 1 clinical trial is a multicenter, double-blind, single ascending dose trial evaluating safety in up to a total of 48 participants across up to 6 dose cohorts, 5 planned and 1 to be determi...
Eligibility Criteria
Inclusion
- The participant provides written informed consent.
- The participant is a male or female (not of childbearing potential), 21 to 65 years of age at time of screening.
- Female participants must have documented proof that they are not of childbearing potential and must not currently be 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.
- The participant must not have participated in a clinical drug trial within 3 months of study start, or within 5 half-lives, unless the study blind has been broken and the participant was known to be on placebo
- The participant must have a body mass index of 18.5 to 30 kg/m\^2
Exclusion
- Any contraindication or inability to undergo lumbar puncture due to anticoagulant use, platelet level, or coagulation study/INR result
- Any significant acute or chronic medical illness
- Any history of cancer within 5 years of enrollment, with the exception of resected skin basal cell carcinoma
- Any major surgery within 4 weeks of study drug administration
- Donation of blood or serum \> 500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration
- Inability to undergo venipuncture or tolerate venous access
- A history of smoking or using tobacco products within 3 months before study drug administration
- A history of drug or alcohol abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse
- Evidence of any clinically significant neurological or psychiatric disorder that could interfere with study assessments as determined by investigator and sponsor
- A history or current status of schizophrenia, schizoaffective disorder or bipolar disorder, untreated major depression (DSM-V or ICD-10 criteria)
- Any significant illness or infection requiring intervention within the prior 30 days as determined by the investigator and sponsor
- An indication of potential suicidality risk based on the C-SSRS assessment
- 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
- A known hypersensitivity to any components of the PNT001 drug product or placebo (5% dextrose)
- Current use of or plan to use any medication (prescription or over-the-counter) that would potentially affect the assessment of the pharmacokinetics, pharmacodynamics, or immunogenicity of PNT001
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04096287
Start Date
September 17 2019
End Date
February 15 2021
Last Update
February 23 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
2
Pacific Research Network, Inc.
San Diego, California, United States, 92103
3
Hassman Research Institute
Marlton, New Jersey, United States, 08053
4
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217