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Monoclonal Antibodies

PMN310 for Healthy Volunteers

Phase 1
Recruiting
Led By Alfredo Fernandez, MD
Research Sponsored by ProMis Neurosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations.
Any non-vasectomized male subjects must agree to use barrier contraceptives (male or female partner condom, diaphragm, cervical cap, sponges) plus spermicide.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days with an optional assessment at day 120
Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and effective. Volunteers needed!

Who is the study for?
This trial is for healthy adults with a BMI between 18 and 32, not planning pregnancy or breastfeeding. Men must use barrier contraception plus spermicide. Participants should have no significant medical history, normal physical exams, vital signs, ECGs, lab tests, and MRI results.Check my eligibility
What is being tested?
The study is testing the safety and how the body processes a single IV infusion of PMN310 compared to a placebo in healthy volunteers. This is an initial test in humans to understand how this potential medication behaves.See study design
What are the potential side effects?
Since this is a first-in-human study of PMN310 in healthy individuals, specific side effects are unknown but will be closely monitored for any adverse reactions related to the infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am generally healthy with no significant medical issues.
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I agree to use barrier contraceptives and spermicide if I am a man who has not had a vasectomy.
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I am a woman who cannot become pregnant, as confirmed by my medical history.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days with an optional assessment at day 120
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days with an optional assessment at day 120 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events
Incidence of clinically significant abnormal findings in 12 Lead electrocardiogram (ECG)
Incidence of clinically significant abnormal findings in laboratory assessments (hematology, serum clinical chemistry, and urinalysis)
+2 more
Secondary outcome measures
Pharmacokinetic properties of PMN310 in CSF
Pharmacokinetic properties of PMN310 in Serum
Other outcome measures
Immunogenicity of PMN310 - anti-drug antibodies (ADAs) in serum

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5 PMN310 2800mg or placeboExperimental Treatment2 Interventions
PMN310 2800mg or placebo administered as a 60-minute infusion.
Group II: Cohort 4 PMN310 1400mg or placeboExperimental Treatment2 Interventions
PMN310 1400mg or placebo administered as a 60-minute infusion.
Group III: Cohort 3 PMN310 700mg or placeboExperimental Treatment2 Interventions
PMN310 700mg or placebo administered as a 60-minute infusion.
Group IV: Cohort 2 PMN310 350mg or placeboExperimental Treatment2 Interventions
PMN310 350mg or placebo administered as a 60-minute infusion.
Group V: Cohort 1 PMN310 175mg or placeboExperimental Treatment2 Interventions
PMN310 175mg or placebo administered as a 60-minute infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ProMis Neurosciences, IncLead Sponsor
Alfredo Fernandez, MDPrincipal InvestigatorClnical Pharmacology of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions available in this medical research project?

"Affirmative. According to information accessible on clinicaltrials.gov, this medical trial is currently seeking patients and have been since November 1st 2023. 40 individuals need to be recruited from a single location with the latest update occurring on 17th of that same month."

Answered by AI

How many individuals are currently being monitored for this research endeavor?

"That is accurate. According to clinicaltrials.gov, this medical trial was initially published on November 1st 2023 and has recently been updated as of the 17th of that same month. Forty patients are required in total from a solitary research site for it's completion."

Answered by AI

Does this clinical trial accept participants of all ages, including those younger than 75?

"This research study is open to patients aged 18 and above, up until their 65th birthday."

Answered by AI

Is consuming Placebo a risk-free endeavor for those who partake?

"Minimal safety data is available for Placebo, so it obtained a score of 1."

Answered by AI

Could I potentially be included in the clinical experiment?

"This clinical trial is enrolling 40 volunteers that are deemed healthy, aged between 18 and 65. To qualify for the study, participants must pass a Screening MRI exam, have no plans or evidence of being able to bear children during the course of the experiment (120 days after drug infusion) and men must use barrier contraception in combination with spermicide. Additionally, they should be medically fit as indicated by their medical history benchmarked against physical exams, vital signs readings ECG results and lab evaluations. Further still, enrollees need to meet body mass index criteria ranging from 18-32 kg/m2 before providing written consent."

Answered by AI

Who else is applying?

What site did they apply to?
Ohio Clinical Trials
Clinical Pharmacology of Miami, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

To help people. I am a super healthy male, looking to volunteer. I have been a part of four other studies before, And would like to be a part of one more.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 1a Study of PMN310 In Healthy Volunteers
2023. "A Phase 1a Study of PMN310 In Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105528.
~11 spots leftby Jul 2024
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