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Monoclonal Antibodies

OPT101 for Staphylococcal Sepsis

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

1. Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed).

2. ≥18 years old;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Staphylococcal Sepsis
Sepsis
Community-acquired Pneumonia

Eligibility Criteria

Inclusion Criteria

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met