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Peptide

OPT101 for Healthy Subjects

Phase 1
Recruiting
Led By Isaac Melamed, MD
Research Sponsored by Op-T LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Has an active fever or has recently been exposed to a COVID-19 patient
Currently has or had a history of malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks- 1 prior to infusion and day 15

Summary

This trial will test a new drug in humans for the first time. It will compare the drug to a placebo, and neither the participants nor the researchers will know who is receiving which. The trial will be conducted in two parts.

Who is the study for?
This trial is for healthy adults aged 18 or older who can consent to the study. Women must test negative for pregnancy and use birth control, as should men with female partners. Participants need to be medically stable without a history of serious blood clots, infections, immune disorders, malignancy, or recent drug/alcohol abuse. They shouldn't have received certain vaccines recently or be over 350lbs or older than 55.
What is being tested?
The trial is testing OPT101 in healthy subjects to see if it's safe and doesn't cause harm. It's a Phase 1 study where participants are randomly assigned to receive either OPT101 or a placebo without knowing which one they get (double-blinded).
What are the potential side effects?
Since this is the first time OPT101 is being tested in humans, potential side effects are unknown but will likely include typical reactions seen with other peptides such as injection site reactions, flu-like symptoms, allergic responses, and possibly others identified during the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have a fever or was recently near someone with COVID-19.
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I have or had cancer before.
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I am over 55 years old.
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I am currently receiving treatment for an autoimmune disease.
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I have not had blood clots, heart attacks, strokes, or recent surgeries.
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I have received a biologic or immunotherapy in the past 6 months.
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I do not have ongoing infections or a history of frequent or severe infections.
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I do not have bleeding disorders or conditions that make blood thinners unsafe for me.
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I plan to have surgery after joining the study.
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I have an immune deficiency or had a bone marrow/organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks- 1 prior to infusion and day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks- 1 prior to infusion and day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Definition of maximum tolerated (MTD) single and repeated doses of OPT101
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence of abnormal laboratory values
+2 more
Secondary study objectives
Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2)
Development of anti-drug antibodies after 1 or more infusions

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OPT101Experimental Treatment1 Intervention
The starting dose for the Phase 1a study is 0.16 mg/kg, which is 35-fold lower than the dog NOAEL (10mg/kg), on a mg/m2 basis. The dosing frequency for the MAD study was selected based on dosing performed in the supporting animal model studies. For an additional safety factor, the dose and volume infusion rates for the 0.16 mg/kg dose in humans will be 67-fold and 14-fold lower than the dogs dosed at 10mg/kg/min and mL/kg/min basis, respectively. For both Phase 1a and 1b, OPT101 will be administered by a slow IV infusion over 30 minutes.
Group II: 0.9% Sodium Chloride Injection USPPlacebo Group1 Intervention
Placebo will be 50 mL normal saline (Sodium Chloride), USP sterile solution administered by IV infusion over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OPT101
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Op-T LLCLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
Isaac Melamed, MDPrincipal InvestigatorIMMUNOe Health Centers
4 Previous Clinical Trials
86 Total Patients Enrolled
~3 spots leftby Oct 2025
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