Healthy ParticipantsPhase 1NCT06105528

A Phase 1a Study of PMN310 In Healthy Volunteers

A Phase 1 study testing PMN310 in people with Healthy Participants, run by ProMis Neurosciences, Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: PMN310
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 18 Nov 2023to 31 Jul 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 14Show fewer

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).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ohio Clinical Trials
Columbus, Ohio, 43212
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy Participants
Being tested: PMN310, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PMN310Drug
60-minute intravenous infusion
PlaceboDrug
60-minute intravenous infusion

Study groups in NCT06105528
Study group	Role	What they receive
Cohort 1 PMN310 175mg or placebo	Experimental	PMN310 175mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo
Cohort 2 PMN310 350mg or placebo	Experimental	PMN310 350mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo
Cohort 3 PMN310 700mg or placebo	Experimental	PMN310 700mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo
Cohort 4 PMN310 1400mg or placebo	Experimental	PMN310 1400mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo
Cohort 5 PMN310 2800mg or placebo	Experimental	PMN310 2800mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment Emergent Adverse Events
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 85 days

Secondary outcomes (8)

Summary of Serum Pharmacokinetic Parameters of PMN310 - AUCinf
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose
Summary of CSF Concentrations of PMN310
Measure concentration of PMN310 in CSF
Measured: Days 3 and 29
Summary of Serum Pharmacokinetic Parameters of PMN310 - AUClast
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - CL
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - Cmax
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - T1/2
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - Tmax
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - Vd
Measure concentration of PMN310 in serum
Measured: 0 to 2040 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202331 Jul 2024

First posted27 Oct 2023
Study start18 Nov 2023
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06105528
Sponsor's protocol ID: PMN310-101
Status last verified: Jul 2025
First submitted: 23 Oct 2023
Last updated: 25 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers
ClinicalTrials.gov ID: NCT06105528
Acronym / sponsor ID: PMN310-101
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: ProMis Neurosciences, IncIndustry (pharma, biotech, devices)
Study start: 18 Nov 2023 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 27 Oct 2023 (actual)
Results: Posted 25 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: 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.

Arm	Type	Receives
Cohort 1 PMN310 175mg or placebo	Experimental	Drug: PMN310, Drug: PlaceboPMN310 175mg or placebo administered as a 60-minute infusion.
Cohort 2 PMN310 350mg or placebo	Experimental	Drug: PMN310, Drug: PlaceboPMN310 350mg or placebo administered as a 60-minute infusion.
Cohort 3 PMN310 700mg or placebo	Experimental	Drug: PMN310, Drug: PlaceboPMN310 700mg or placebo administered as a 60-minute infusion.
Cohort 4 PMN310 1400mg or placebo	Experimental	Drug: PMN310, Drug: PlaceboPMN310 1400mg or placebo administered as a 60-minute infusion.
Cohort 5 PMN310 2800mg or placebo	Experimental	Drug: PMN310, Drug: PlaceboPMN310 2800mg or placebo administered as a 60-minute infusion.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PMN31060-minute intravenous infusion	Drug	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
Placebo60-minute intravenous infusion	Drug	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

Primary outcome

Incidence of Treatment Emergent Adverse Events
Time frame: 85 days
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Incidence of Clinically Significant Abnormal Findings in Laboratory Assessments (Hematology, Serum Clinical Chemistry, and Urinalysis)
Time frame: 85 days
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Incidence of Clinically Significant Abnormal Findings in Physical Examinations Including Neurological Examinations
Time frame: 85 days
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Incidence of Clinically Significant Abnormal Findings in Vital Signs (Supine Blood Pressure (BP), Pulse, Respiratory Rate and Oral Body Temperature)
Time frame: 85 days
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Incidence of Clinically Significant Abnormal Findings in 12 Lead Electrocardiogram (ECG)
Time frame: 85 days
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.

8 secondary outcomes

Summary of Serum Pharmacokinetic Parameters of PMN310 - AUCinf
Time frame: 0 to 2040 hours post-dose
Summary of CSF Concentrations of PMN310
Time frame: Days 3 and 29
Summary of Serum Pharmacokinetic Parameters of PMN310 - AUClast
Time frame: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - CL
Time frame: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - Cmax
Time frame: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - T1/2
Time frame: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - Tmax
Time frame: 0 to 2040 hours post-dose
Summary of Serum Pharmacokinetic Parameters of PMN310 - Vd
Time frame: 0 to 2040 hours post-dose

Results and safety

Results posted to the registry on 25 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PMN310 175 mg	6	6
PMN310 350 mg	6	6
PMN310 700 mg	6	6
PMN310 1400 mg	6	6
PMN310 2800 mg	6	6
Placebo	10	10

Primary outcome: Incidence of Treatment Emergent Adverse Events

Time frame: 85 days. Number. Unit: participants

Measure	PMN310 175 mg n = 6	PMN310 350 mg n = 6	PMN310 1400 mg n = 6	PMN310 2800 mg n = 6	Placebo n = 10
Any TEAE	2	2	3	3	3
Any TEAE Related to Study Treatment	1	1	0	1	2
Any Severity Grade 3 TEAE	1	0	0	1	1
Any TESAE	0	0	0	0	0
Any TEAE Leading to Treatment Discontinuation	0	0	0	0	0

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

Time frame: 85 days. Number. Unit: participants

Measure	PMN310 175 mg n = 6	PMN310 350 mg n = 6	PMN310 700 mg n = 6	PMN310 1400 mg n = 6	PMN310 2800 mg n = 6	Placebo n = 10
Value	0	0	0	0	0	0

Primary outcome: Incidence of Clinically Significant Abnormal Findings in Physical Examinations Including Neurological Examinations

Time frame: 85 days. Number. Unit: participants

Measure	PMN310 175 mg n = 6	PMN310 350 mg n = 6	PMN310 700 mg n = 6	PMN310 1400 mg n = 6	PMN310 2800 mg n = 6	Placebo n = 10
Value	0	0	0	0	0	0

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

Time frame: 85 days. Number. Unit: participants

Measure	PMN310 175 mg n = 6	PMN310 350 mg n = 6	PMN310 700 mg n = 6	PMN310 1400 mg n = 6	PMN310 2800 mg n = 6	Placebo n = 10
Value	0	0	0	0	0	0

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 85 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PMN310 175 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PMN310 350 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PMN310 700 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
PMN310 1400 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PMN310 2800 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Placebo	0 of 10 (0%)	3 of 10 (30%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alfredo Fernandez, MD principal investigator

Clnical Pharmacology of Miami

Alexander N Prezioso, MD principal investigator

Clnical Pharmacology of Miami

Angela Eakin, MD principal investigator

Ohio Clinical Trials

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PMN310 in people with Healthy Participants, run by ProMis Neurosciences, Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (time frame: 85 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06105528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.