A Phase 1 interventional study of PNT001 and Placebo in Healthy, sponsored by Pinteon Therapeutics, Inc. Completed at 4 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by Pinteon Therapeutics, Inc · Phase 1, Interventional, and Treatment
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 intravenous PNT001 in healthy adult participants.
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 determined if an additional dose group is required. Each cohort will include 8 participants (6 active, 2 placebo) who will receive a single dose of either PNT001 or placebo. Within each cohort a sentinel group of 2 participants (1 active, 1 placebo) will be enrolled to evaluate safety and tolerability before enrolling the full cohort. If there are no safety concerns (as determined by the data and safety monitoring board [DSMB]), the remaining 6 participants (randomized as 5 active, 1 placebo) will be enrolled. This process will be followed for all additional cohorts.
After screening, and laboratory assessments at Day -1, eligible participants will be admitted to the research unit on Day 1 (or Day -1 at Investigator's discretion), where they will remain for three (or four) nights with standardized meals provided during their inpatient stay. On Day 1, participants will be randomized to receive either active drug or placebo. Study medication will be administered as a single i.v. infusion over 30 minutes (up to 60 minutes for doses greater than 2,700 mg), followed by collection of safety, tolerability, and PK data over 16 weeks. Participants will be discharged on Day 4 and will return for an outpatient study visit on Day 5 (may be phone or clinic visit), and to the study site on Days 7, 14, 28, 42, 56, 70, 84, 98, and 112.
Pinteon Therapeutics, Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single escalating doses of intravenous PNT001 administered as a 30 minute infusion at doses of 33mg, 100mg, 300mg, 900mg, 2700mg, and as a 60 minute infusion at 4000 mg
Biological: PNT001
Single intravenous dose of vehicle administered as a 30 minute infusion up to 2700 mg and as a 60 minute infusion at 4000 mg
Drug: Placebo
PNT001 diluted in 5% dextrose
5% dextrose
Incidence of Treatment Emergent Adverse Events
assess adverse events during 16 week duration of study
Time frame: 16 weeks
Incidence of Treatment Emergent Clinical Laboratory Test Abnormalities
measure clinical laboratory values during 16 week duration of study
Time frame: 16 weeks
Incidence of Treatment Emergent Abnormalities in Physical Examination Findings
observe skin, eyes, ears, nose, throat, cardiac and pulmonary status, abdomen, and extremities for any abnormalities
Time frame: 16 weeks
Incidence of Treatment Emergent Abnormalities in Neurological Examination Findings
perform a neurological assessment of orientation, cranial nerve function, limb function for presence of involuntary movements, muscle mass, tone, and strength, coordination, reflexes, sensation, joint position, gait, Romberg test
Time frame: 16 weeks
Incidence of Treatment Emergent Abnormalities in Blood Pressure
measure resting pulse rate as beats per minute
Time frame: 16 weeks
Incidence of Treatment Emergent Abnormalities in Pulse Rate
measure systolic and diastolic blood pressure in mmHg
Time frame: 16 weeks
Incidence of Treatment Emergent Abnormalities in 12 lead Electrocardiogram Assessment
measure QT and calculate QTcF value
Time frame: 16 weeks
Pharmacokinetic properties of PNT001 in Serum
measure concentration of PNT001 in serum
Time frame: 16 weeks
Pharmacokinetic properties of PNT001 in Cerebrospinal Fluid (CSF)
measure concentration of PNT001 in CSF
Time frame: 28 days
Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - total tau
measure CSF concentrations of total tau
Time frame: 28 days
Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - cis-pT231 tau
measure CSF concentrations of cis-pT231 tau
Time frame: 28 days
Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - total pT231 tau
measure CSF concentrations of total pT231 tau
Time frame: 28 days
Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - NfL
measure CSF concentrations of Neurofilament Light Chain (NfL)
Time frame: 28 days
Pharmacodynamic effects of PNT001 in Serum - NfL
measure serum concentrations of Neurofilament Light Chain (NfL)
Time frame: 28 days
Immunogenicity of PNT001 - ADA
measure presence of antidrug antibodies (ADA) in serum
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Pinteon Therapeutics, Inc