OPT101 for Community-Acquired Pneumonia

Overseen By Marc L Giles, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Op-T LLC

Must not be taking: Immunosuppressants

Disqualifiers: Hepatic dysfunction, Renal dysfunction, HIV, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

OPT101-100-40 is a multicenter, randomized, placebo-controlled, multiple-ascending-dose, sequential-group, investigator- and participant-blinded, sponsor-unblinded, study of OPT101 vs placebo when administered for up to 4 days to patients admitted to the hospital for treatment of Community Acquired Pneumonia (CAP) with sepsis. This study will be performed in patients with Community Acquired Pneumonia (CAP) with Sepsis, who are 18 years or older to evaluate the safety and tolerability of OPT101 in a population with elevated levels of pathologic CD40.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that treatment with certain prohibited medications must be stopped within 5 half-lives before starting the trial and cannot be used during the treatment period. It's best to discuss your specific medications with the trial team.

What safety data exists for the treatment OPT101?

The OptiMARK clinical development program provides safety data for OPT101, summarizing its safety profile from previous evaluations. ^{1 2 3 4 5}

Who Is on the Research Team?

Herbert B Slade, MD FAAAAI

Principal Investigator

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am using birth control as a woman able to have children.

Able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed)

I need extra oxygen through a device.

Exclusion Criteria

Pregnancy-related criteria

I expect to leave the hospital or be transferred within 2 days of screening.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive OPT101 or placebo for up to 4 days

4 days

Daily visits (in-person) during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OPT101

Trial Overview 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.

How Is the Trial Designed?

Group I: OPT101 Experimental Treatment 1 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 USP Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Op-T LLC

Lead Sponsor

Trials

3

Recruited

60+

Published Research Related to This Trial

In a clinical development program involving 1684 subjects and 2038 injections, OptiMARK demonstrated a safety profile comparable to Magnevist, with 31% of its injections associated with adverse events.

OptiMARK was found to be safe and well-tolerated, showing fewer adverse events compared to Magnevist (35%) and placebo (48%), indicating its potential as a reliable imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. Brown, JJ., Kristy, RM., Stevens, GR., et al.[2019]

A review of safety alerts from major health regulatory authorities identified 38 alerts related to ocular adverse events from systemic drugs, with urological medications being the most frequently implicated.

The most common ocular issues reported were visual disorders, such as visual impairment and blurred vision, highlighting the need for physicians to monitor and address these drug-induced effects to prevent progression and potential vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade. Penedones, A., Mendes, D., Alves, C., et al.[2022]

In a 5-year study at a Finnish tertiary hospital, the Global Trigger Tool (GTT) identified 53 adverse drug events (ADEs) among 834 patient records, indicating a rate of 13 ADEs per 1000 patient-days and affecting 6% of patients.

The study found that as the number of medication-related triggers increased, so did the likelihood of experiencing an ADE, suggesting that the GTT medication module is useful for detecting potential risks, although modifications could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. Valkonen, V., Haatainen, K., Saano, S., et al.[2023]

The extended Liverpool Adverse Event Profile (E AEP) was used to analyze side effects in 1,605 epilepsy patients and 537 healthy subjects, revealing that many reported symptoms were not directly related to anti-seizure medication (ASM) after normalization for age and gender.

The study found that while medication choice influenced side effect complaints, the E AEP's ability to differentiate between physical and psychological domains was stronger, suggesting that a norm-referenced approach is crucial for accurately assessing treatment-related problems in epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normalization and cross-sectional validation of an extended Adverse Event Profile (E AEP) in a large cohort of patients with epilepsy. Helmstaedter, C., Meschede, C., Mastani, S., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights October - December 2016. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Normalization and cross-sectional validation of an extended Adverse Event Profile (E AEP) in a large cohort of patients with epilepsy. [2023]