A Phase 1a Study of PMN310 In Healthy Volunteers

A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PMN310; Drug: Placebo

Detailed Description

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses of intravenous PMN310 in healthy adult volunteers.

Subjects will be randomly assigned to receive either a single infusion of PMN310 or placebo. After randomization on Day 1, study drug will be administered followed by the collection of safety, tolerability, and PK data.

All dose cohorts will have lumbar punctures (LPs) for PK analysis performed on Day 3 and Day 29. Primary PK and CSF data will be obtained from Day 1 to Day 29. Safety and tolerability will be collected at all visits. The study is an 85-day study with one optional follow up assessment at Day 120.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cheryl Duggan; Phone Number: (305) 817 2900; Email: cduggan@ergclinical.com
• Study Contact Backup: Name: PMN310-101 Call Line; Phone Number: (617) 250 0365

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Recruiting
      • Clinical Pharmacology of Miami, LLC
      • Contact: Cheryl Duggan; Phone Number: 305-817-2900; Email: cduggan@ergclinical.com
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Ohio Clinical Trials
      • Contact: Angela Eakin, MD; Phone Number: 614-298-8086; Email: aeakin@ergclinical.com
      • Principal Investigator: Angela Eakin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Female subjects of non-childbearing potential must have evidence from their medical history indicating that they are not of childbearing potential.
3. Any non-vasectomized male subjects must agree to use barrier contraceptives (male or female partner condom, diaphragm, cervical cap, sponges) plus spermicide.
4. Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations.
5. Has provided written informed consent.
6. Body mass index is between 18 and 32 kg/m2 (inclusive).
7. Screening MRI normal.

Exclusion Criteria:

1. Clinically significant 12-lead ECG abnormality at Screening.
2. Systolic blood pressure > 150 bpm or diastolic blood pressure > 90 bpm at Screening.
3. Experienced a significant systemic illness within 30 days of the first dose of study drug.
4. 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.
5. Currently using any medication except for acetaminophen as needed for miscellaneous aches and pains.
6. History of alcohol abuse and/or illicit drug use within 12 months prior dosing or a smoking history (use of tobacco products).
7. Unwilling to refrain from ingesting alcohol within the limits required by the Study.
8. Positive urine drug screen.
9. History of prior malignancy.
10. 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.
11. Donated blood or blood products (e.g., plasma, platelets) within 28 days prior to first dose.
12. Received an investigational agent within the last 30 days or 5 half-lives (if known) prior to Screening, whichever is longer.
13. Contraindication to brain venipuncture, MRI or LP.
14. Indication of potential suicidality risk as identified by the following Columbia-Suicide Severity Rating Scale (C SSRS).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 PMN310 175mg or placebo; PMN310 175mg or placebo administered as a 60-minute infusion.	Drug: PMN310; 60-minute intravenous infusion; Drug: Placebo; 60-minute intravenous infusion
Experimental: Cohort 2 PMN310 350mg or placebo; PMN310 350mg or placebo administered as a 60-minute infusion.	Drug: PMN310; 60-minute intravenous infusion; Drug: Placebo; 60-minute intravenous infusion
Experimental: Cohort 3 PMN310 700mg or placebo; PMN310 700mg or placebo administered as a 60-minute infusion.	Drug: PMN310; 60-minute intravenous infusion; Drug: Placebo; 60-minute intravenous infusion
Experimental: Cohort 4 PMN310 1400mg or placebo; PMN310 1400mg or placebo administered as a 60-minute infusion.	Drug: PMN310; 60-minute intravenous infusion; Drug: Placebo; 60-minute intravenous infusion
Experimental: Cohort 5 PMN310 2800mg or placebo; PMN310 2800mg or placebo administered as a 60-minute infusion.	Drug: PMN310; 60-minute intravenous infusion; Drug: Placebo; 60-minute intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic properties of PMN310 in Serum	Measure concentration of PMN310 in serum	85 days with an optional assessment at Day 120
Pharmacokinetic properties of PMN310 in CSF	Measure concentration of PMN310 in CSF	85 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of PMN310 - anti-drug antibodies (ADAs) in serum	Assessment of the immunogenicity of PMN310 following a single intravenous dose	85 days with an optional assessment at Day 120

Collaborators and Investigators

• Sponsor: ProMis Neurosciences, Inc
• Investigators: Principal Investigator: Alfredo Fernandez, MD, Clnical Pharmacology of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PMN310-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No