SepsisPhase 1NCT06669403
OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
A Phase 1 study testing OPT101 in people with Sepsis and Community Acquired Pneumonia (CAP), run by Op-T LLC at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Community Acquired Pneumonia (CAP)
- What is being tested?
- OPT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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
- A male sexual partner who agrees to use a male condom with spermicide
- A sterile sexual partner
Who cannot join
- 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)
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- 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
- Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism
- Weight is over 250lbs
- Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study. The Principal Investigator should make this determination in consideration of the patient's medical history and current clinical condition.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
Terra Miller, MSN, RN, 303-602-1438, Terra.Hiller@dhha.org
Ivor S Douglas, MD
About this study
Official title: A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
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)
- Being tested
- OPT101, Placebo
- Keywords
- Sepsis, Community Acquired Pneumonia (CAP), Immunomodulator, OPT101, Op-T LLC
- Medical subject headings
- Sepsis, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT101Drug
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.
PlaceboOther
Also called Placebeo
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: OPT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0
Measured: 30 days
Incidence of serious adverse events (SAEs)
SAEs will be recorded and assessed by CTCAE v4.0
Measured: 30 days
Incidence of TEAEs leading to study drug discontinuation
Measured: 30 days
Incidence and characteristics of presumed infusion reactions
Recorded as an adverse event
Measured: 30 days
Secondary outcomes (5)
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine AUCO-24
Measured: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Cmax
Measured: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Tmax
Measured: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine t1/2
Measured: 30 days
To measure the serum pharmacokinetics of OPT101
Serum concentrations of OPT101 to determine Vz/F
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study startDec 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Op-T LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD FAAAAI, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669403
- Sponsor's protocol ID
- OPT101-100-40
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis
- ClinicalTrials.gov ID
- NCT06669403
- Acronym / sponsor ID
- OPT101-100-40
- Conditions
- Sepsis, Community Acquired Pneumonia (CAP)
- Keywords
- Sepsis, Community Acquired Pneumonia (CAP), Immunomodulator, OPT101, Op-T LLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Op-T LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% Sodium Chloride Injection USP | Placebo comparator | Other: PlaceboPlacebo will be 50mL normal saline (Sodium Chloride), USP sterile solution provided in a 50mL pre-packaged Intravenous (IV) bag. |
| OPT101 | Experimental | Drug: OPT101OPT101 (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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:
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPT101OPT101, 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. | Drug | OPT101 |
| PlaceboAlso: Placebeo0.9% 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. | Other | 0.9% Sodium Chloride Injection USP |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 30 days
Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0
Incidence of serious adverse events (SAEs)
Time frame: 30 days
SAEs will be recorded and assessed by CTCAE v4.0
Incidence of TEAEs leading to study drug discontinuation
Time frame: 30 days
Incidence and characteristics of presumed infusion reactions
Time frame: 30 days
Recorded as an adverse event
5 secondary outcomes
To measure the serum pharmacokinetics of OPT101
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Time frame: 30 days
To measure the serum pharmacokinetics of OPT101
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Herbert B Slade, MD FAAAAI study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPT101 in people with Sepsis and Community Acquired Pneumonia (CAP), run by Op-T LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Boswell, MS (720-315-0198, lmboswell@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.