Phase 1 N=40 Randomized Double-blind Treatment

A Phase 1a Study of PMN310 In Healthy Volunteers

Healthy Participants

Bottom Line

View on ClinicalTrials.gov: NCT06105528 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Incidence of Treatment Emergent Adverse Events — 2; 2; 0; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PMN310 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ProMis Neurosciences, Inc
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Treatment Emergent Adverse Events	2; 2; 0; 3; 3; 3	—
PRIMARY Incidence of Clinically Significant Abnormal Findings in Laboratory Assessments (Hematology, Serum Clinical Chemistry, and Urinalysis)	0; 0; 0; 0; 0; 0	—
PRIMARY Incidence of Clinically Significant Abnormal Findings in Physical Examinations Including Neurological Examinations	0; 0; 0; 0; 0; 0	—
PRIMARY Incidence of Clinically Significant Abnormal Findings in Vital Signs (Supine Blood Pressure (BP), Pulse, Respiratory Rate and Oral Body Temperature)	0; 0; 0; 0; 0; 0	—
PRIMARY Incidence of Clinically Significant Abnormal Findings in 12 Lead Electrocardiogram (ECG)	0; 0; 0; 0; 0; 0	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - AUCinf	19500000; 54800000; 91400000; 17300000; 417000000	—
SECONDARY Summary of CSF Concentrations of PMN310	50.05; 78.47; 150.10; 284.00; 502.50; 32.43	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - AUClast	18900000; 49800000; 86300000; 16700000; 40000000	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - CL	0.00911; 0.00737; 0.00788; 0.00824; 0.00693	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - Cmax	88300; 350000; 337000; 704000; 1480000	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - T1/2	385.44; 491.61; 456.26; 440.09; 394.02	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - Tmax	2.25; 5.75; 1.75; 2.75; 7.25	—
SECONDARY Summary of Serum Pharmacokinetic Parameters of PMN310 - Vd	5.08; 5.08; 5.22; 5.17; 4.32	—

Summary

This first in human Phase 1a clinical trial will evaluate the safety, tolerability, and pharmacokinetics of a single IV infusion of PMN310 in healthy volunteers.

Eligibility Criteria

Inclusion Criteria

Female subjects of childbearing potential must not be breastfeeding and must have no plans to become pregnant during the course of the study through 120 days after infusion of study drug.
Female subjects of non-childbearing potential must have evidence from their medical history indicating that they are not of childbearing potential.
Any non-vasectomized male subjects must agree to use barrier contraceptives (male or female partner condom, diaphragm, cervical cap, sponges) plus spermicide.
Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations.
Has provided written informed consent.
Body mass index is between 18 and 32 kg/m2 (inclusive).
Screening MRI normal.

Exclusion Criteria

Clinically significant 12-lead ECG abnormality at Screening.
Systolic blood pressure > 150 bpm or diastolic blood pressure > 90 bpm at Screening.
Experienced a significant systemic illness within 30 days of the first dose of study drug.
Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Currently using any medication except for acetaminophen as needed for miscellaneous aches and pains.
History of alcohol abuse and/or illicit drug use within 12 months prior dosing or a smoking history (use of tobacco products).
Unwilling to refrain from ingesting alcohol within the limits required by the Study.
Positive urine drug screen.
History of prior malignancy.
Documented history of human immunodeficiency virus (HIV) antibody or tested positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at Screening.
Donated blood or blood products (e.g., plasma, platelets) within 28 days prior to first dose.
Received an investigational agent within the last 30 days or 5 half-lives (if known) prior to Screening, whichever is longer.
Contraindication to brain venipuncture, MRI or LP.
Indication of potential suicidality risk as identified by the following Columbia-Suicide Severity Rating Scale (C SSRS).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06105528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.