A Phase 1a Study of PMN310 In Healthy Volunteers

NCT06105528 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: PMN310-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment Emergent Adverse Events

  Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.

  85 days

• Incidence of Clinically Significant Abnormal Findings in Laboratory Assessments (Hematology, Serum Clinical Chemistry, and Urinalysis)

  Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.

  85 days

• Incidence of Clinically Significant Abnormal Findings in Physical Examinations Including Neurological Examinations

  Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.

  85 days

• Incidence of Clinically Significant Abnormal Findings in Vital Signs (Supine Blood Pressure (BP), Pulse, Respiratory Rate and Oral Body Temperature)

  Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.

  85 days

• Incidence of Clinically Significant Abnormal Findings in 12 Lead Electrocardiogram (ECG)

  Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.

  85 days

Secondary Outcomes (8)

• Summary of Serum Pharmacokinetic Parameters of PMN310 - AUCinf

  0 to 2040 hours post-dose

• Summary of CSF Concentrations of PMN310

  Days 3 and 29

• Summary of Serum Pharmacokinetic Parameters of PMN310 - AUClast

  0 to 2040 hours post-dose

• Summary of Serum Pharmacokinetic Parameters of PMN310 - CL

  0 to 2040 hours post-dose

• Summary of Serum Pharmacokinetic Parameters of PMN310 - Cmax

  0 to 2040 hours post-dose

Other Outcomes (1)

• Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum

  85 days

Study Arms (5)

Cohort 1 PMN310 175mg or placebo

EXPERIMENTAL

PMN310 175mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Cohort 2 PMN310 350mg or placebo

EXPERIMENTAL

PMN310 350mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Cohort 3 PMN310 700mg or placebo

EXPERIMENTAL

PMN310 700mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Cohort 4 PMN310 1400mg or placebo

EXPERIMENTAL

PMN310 1400mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Cohort 5 PMN310 2800mg or placebo

EXPERIMENTAL

PMN310 2800mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Interventions

PMN310 DRUG

60-minute intravenous infusion

Cohort 1 PMN310 175mg or placebo; Cohort 2 PMN310 350mg or placebo; Cohort 3 PMN310 700mg or placebo; Cohort 4 PMN310 1400mg or placebo; Cohort 5 PMN310 2800mg or placebo

Placebo DRUG

60-minute intravenous infusion

Cohort 1 PMN310 175mg or placebo; Cohort 2 PMN310 350mg or placebo; Cohort 3 PMN310 700mg or placebo; Cohort 4 PMN310 1400mg or placebo; Cohort 5 PMN310 2800mg or placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ProMis Neurosciences, Inc: lead

Study Sites (2)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

Results Point of Contact

• Title: Wendy Luca
• Organization: ProMIS Neurosciences, Inc.

promisclinical@promisneurosciences.com

617-250-0365

Study Officials

• Alfredo Fernandez, MD

  Clnical Pharmacology of Miami

  PRINCIPAL INVESTIGATOR

• Alexander N Prezioso, MD

  Clnical Pharmacology of Miami

  PRINCIPAL INVESTIGATOR

• Angela Eakin, MD

  Ohio Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 5 sequential escalating dose cohort groups. Dose groups are 175 mg, 350 mg, 700 mg, 1400 mg and 2800 mg (optional) administered as a single 60-minute infusion.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: November 18, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)