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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Op-T LLC
Study ID
NCT06669403
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Community Acquired Pneumonia (CAP)
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 0.9% Sodium Chloride Injection USP
    Placebo will be 50mL normal saline (Sodium Chloride), USP sterile solution provided in a 50mL pre-packaged Intravenous (IV) bag.
  • Experimental: OPT101
    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.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Denver Health and Hospital AuthorityDenverColorado80204
Terra Miller, MSN, RN
[email protected]
303-602-1438
Ivor S Douglas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By research site
Denver Health and Hospital Authority· Denver, CO

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