OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

NCT06669403 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OPT101-100-40
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Community Acquired Pneumonia (CAP)

Keywords

Sepsis; Community Acquired Pneumonia (CAP); Immunomodulator; OPT101; Op-T LLC

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAEs)

  Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0

  30 days

• Incidence of serious adverse events (SAEs)

  SAEs will be recorded and assessed by CTCAE v4.0

  30 days

• Incidence of TEAEs leading to study drug discontinuation

  30 days

• Incidence and characteristics of presumed infusion reactions

  Recorded as an adverse event

  30 days

Secondary Outcomes (5)

• To measure the serum pharmacokinetics of OPT101

  30 days

• To measure the serum pharmacokinetics of OPT101

  30 days

• To measure the serum pharmacokinetics of OPT101

  30 days

• To measure the serum pharmacokinetics of OPT101

  30 days

• To measure the serum pharmacokinetics of OPT101

  30 days

Other Outcomes (8)

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

  30 days

• To observe the changes in degree of sepsis via Sequential Organ Failure Assessment (SOFA) score

  30 days

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

  30 days

Study Arms (2)

0.9% Sodium Chloride Injection USP

PLACEBO COMPARATOR

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

Other: Placebo

OPT101

EXPERIMENTAL

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.

Drug: OPT101

Interventions

OPT101 DRUG

OPT101, is a 15-mer peptide derived from the sequence of mouse CD40L and was designed to target CD40-mediated inflammation. On the day of administration, the product will be diluted in saline to result in 50 mL for intravenous (IV) infusion over 120 minutes.

OPT101

Placebo OTHER

0.9% Sodium Chloride Injection USP, Placebo. On the day of administration, a 50mL IV bag containing saline (0.9% Sodium Chloride Injection USP) which will serve as the placebo will be administered via intravenous (IV) infusion over 120 minutes.

Also known as: Placebeo

0.9% Sodium Chloride Injection USP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed).
• ≥18 years old;
• Patients hospitalized for clinically suspected community acquired pneumonia (CAP), defined as the occurrence of (within 48h from hospital admission) at least 1 of the following signs:
• respiratory rate \> 30 breaths/min;
• fever (\> 38.0°C or \> 100.4° F);
• leukopenia (≤ 4,000 WBC/mm3 or leukocytosis (≥ 12,000 WBC/mm3);
• adults ≥ 70 years of age; altered mental status with no other recognized cause;
• AND at least 1 of the following:
• New onset of purulent sputum or change in character of sputum or increased respiratory secretions;
• New onset or worsening cough, or dyspnea, or tachypnea;
• Rales or bronchial breath sounds; AND Radiologic imaging (chest x-ray or CT scan) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation AND SpO2 \<92% at room air, or PaO2/FiO2 (or SpO2/FiO2) \<300; recorded on one episode
• Need for non-invasive supplemental oxygen (nasal cannula, simple mask, venturi or reservoir cannula/mask or heated high flow nasal cannula oxygen.
• Females of child-bearing potential who are sexually active must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:
• Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last OPT101 dose
• A non-hormonal intrauterine device \[IUD\] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last OPT101 dose

You may not qualify if:

• Need for endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at time of study screening
• QTc ≥ 450 msec on screening ECG
• Hepatic dysfunction: ALT or AST \> 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score ≥ 12)
• Recent or active hepatitis A infection; test positive or have been treated for hepatitis B, hepatitis C, or HIV infection; evidence of active or untreated latent TB; a recent history of recurrent herpes zoster and/or opportunistic infection; and/or taking immunosuppressant medication.
• Renal dysfunction: estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73 m2, or need for hemodialysis or hemofiltration
• Current use of \>2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC \< local LLN), solid organ or bone marrow transplant recipients)
• Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period
• Anticipated discharge from the hospital or transfer to another hospital within 48 hours of screening
• Allergy to OPT101or any component of OPT101 formulation
• Participation in other interventional clinical trials
• Pregnancy:
• positive or missing pregnancy test before first drug intake or day 1
• pregnant or lactating women;
• Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study
• Current hospital stay \>72h

Sponsors & Collaborators

• Op-T LLC: lead

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Sepsis; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Herbert B Slade, MD FAAAAI

  STUDY DIRECTOR

Central Study Contacts

Lisa M Boswell, MS

CONTACT

720-315-0198; lmboswell@live.com

Marc L Giles, BS

CONTACT

720-315-0198; mg@op-t.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)