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Monoclonal Antibodies

OPT101 for Community-Acquired Pneumonia

Phase 1

Waitlist Available

Research Sponsored by Op-T LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years old

Need for non-invasive supplemental oxygen

Must not have

Renal dysfunction: estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2, or need for hemodialysis or hemofiltration

Treatment with prohibited medication within 5 half-lives

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Summary

This trial will test a new drug called OPT101 in patients admitted to the hospital with Community Acquired Pneumonia and sepsis. The study is looking at the safety and tolerability of

Who is the study for?

Adults over 18 with Community Acquired Pneumonia and sepsis, needing oxygen but not severe interventions like intubation. They must be able to consent and stay in the hospital for the trial duration. Excluded are pregnant individuals, those with renal or hepatic dysfunction, certain heart conditions, heavy immunosuppression, weight over 250lbs, or allergies to OPT101.

What is being tested?

The study tests OPT101 against a placebo in patients hospitalized with CAP and sepsis. It's blinded for participants and investigators but not the sponsor. The goal is to see if OPT101 is safe and tolerable when given for up to four days.

What are the potential side effects?

While specific side effects of OPT101 aren't listed here, common ones may include allergic reactions due to drug components or potential issues related to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I need extra oxygen through a device.

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I am hospitalized with symptoms that doctors think are pneumonia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low, with an eGFR below 50, or I need dialysis.

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I have not taken any forbidden medications recently.

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I am currently taking more than two medications to suppress my immune system.

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My weight is over 250lbs.

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I am on a ventilator or ECMO machine currently.

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I have a history of infections or am on immunosuppressant medication.

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My liver isn't working well, with high enzyme levels or a chronic condition.

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I have been in the hospital for more than 72 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and characteristics of presumed infusion reactions

Incidence of serious adverse events (SAEs)

Incidence of treatment-emergent adverse events (TEAEs)

Secondary study objectives

To measure the serum pharmacokinetics of OPT101

Other study objectives

Evaluate Pharmacodynamic Effects of OPT101

To observe the changes in degree of sepsis via Cytokine Release Syndrome (CRS) grading

To observe the changes in degree of sepsis via Pneumonia Severity Index (PSI)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OPT101Experimental Treatment1 Intervention

OPT101 (15-mer peptide) will be provided across 2 cohorts at 1.1 (cohort 1) and 2.8 mg/kg (cohort 2) doses . On the day of administration, the product will be diluted in saline to result in 50 mL for intravenous (IV) infusion over 120 minutes.

Group II: 0.9% Sodium Chloride Injection USPPlacebo Group1 Intervention

Placebo will be 50mL normal saline (Sodium Chloride), USP sterile solution provided in a 50mL pre-packaged Intravenous (IV) bag.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OPT101

2022

Completed Phase 1

~30

0 / 11Eligibility criteria met