HealthyPhase 1NCT04589403
1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.
A Phase 1 study testing OPT101 in people with Healthy, run by Op-T LLC at 1 site in United States.
Trial summary
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 27 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to give informed consent for the trial
- Male or female aged ≥18 years on the day of signing informed consent
- Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening
- Women of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
- Women must agree to use one of the following methods of birth control for the duration of the clinical trial: systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
Who cannot join
- Is over the age of 55 years old
- Positive COVID test at screening/baseline
- Has an active fever or has recently been exposed to a COVID-19 patient.
- Currently has or had a history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
- Is currently being treated for an autoimmune disease/s
Show all 52Show fewer
- Subjects with a history of venous and arterial thromboembolic events including, but not limited to, the following: deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene should be excluded. In addition, subjects with recent immobilization or recent surgery, should be excluded. Subjects with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome should also be excluded.
- Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus (EBV), cytomegalovirus (CMV) chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
- Has recent or active hepatitis A infection, current/chronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) may be eligible to participate.
- Has history of immune suppression disorders
- Has received a live (attenuated) vaccine within the last 60 days, including subjects who plan to receive live (attenuated) vaccines during the study or within 60 days after the final dose of study treatment.
- Has received influenza vaccine within 14 days of screening.
- Has received a biologic or immunotherapy in the last 6 months (If receiving allergy shots with stable dosing, is acceptable)
- Has received prescription or non-prescription medication and in the opinion of the Investigator, the product will interfere with the study procedures or data integrity or compromise the safety of the subject.
- Subjects with clinically significant abnormal laboratory test values in screening blood samples. In particular subjects with the following should be excluded:
- Subjects with abnormal coagulation panel at screening such as abnormal PT or aPTT or fibrinogen
- Abnormal liver function tests:
- Liver enzyme abnormalities (except in the case of known Gilbert's syndrome) AST or ALT ≥3x ULN and total bilirubin ≥2x ULN AST or ALT ≥5x ULN AST or ALT ≥3x ULN if associated with appearance or worsening of rash or hepatitis symptoms Abnormal platelet counts (<150,000/mcL or > 450,000/mcL) Abnormal white blood cell counts (<3E3/uL or > 11E3/uL ) Abnormal eGFR (<60 mL/min/1.73m2) Elevated IgE level above 50 IU/mL
- Subjects planning to undergo Elective procedures or surgeries at any time after signing the ICF through the follow-up visit.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting withInclusion :
- Able and willing to give informed consent for the trial
- Male or female aged ≥18 years on the day of signing informed consent
- Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening
- Women of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
- Women must agree to use one of the following methods of birth control for the duration of the clinical trial: systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
- Is over the age of 55 years old
- Positive COVID test at screening/baseline
- Has an active fever or has recently been exposed to a COVID-19 patient.
- Currently has or had a history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
- Is currently being treated for an autoimmune disease/s
- Subjects with a history of venous and arterial thromboembolic events including, but not limited to, the following: deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene should be excluded. In addition, subjects with recent immobilization or recent surgery, should be excluded. Subjects with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome should also be excluded.
- Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus (EBV), cytomegalovirus (CMV) chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
- Has recent or active hepatitis A infection, current/chronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) may be eligible to participate.
- Has history of immune suppression disorders
- Has received a live (attenuated) vaccine within the last 60 days, including subjects who plan to receive live (attenuated) vaccines during the study or within 60 days after the final dose of study treatment.
- Has received influenza vaccine within 14 days of screening.
- Has received a biologic or immunotherapy in the last 6 months (If receiving allergy shots with stable dosing, is acceptable)
- Has received prescription or non-prescription medication and in the opinion of the Investigator, the product will interfere with the study procedures or data integrity or compromise the safety of the subject.
- Subjects with clinically significant abnormal laboratory test values in screening blood samples. In particular subjects with the following should be excluded:
- Subjects with abnormal coagulation panel at screening such as abnormal PT or aPTT or fibrinogen
- Abnormal liver function tests:
- Liver enzyme abnormalities (except in the case of known Gilbert's syndrome)
- AST or ALT ≥3x ULN and total bilirubin ≥2x ULN AST or ALT ≥5x ULN AST or ALT ≥3x ULN if associated with appearance or worsening of rash or hepatitis symptoms Abnormal platelet counts (<150,000/mcL or > 450,000/mcL) Abnormal white blood cell counts (<3E3/uL or > 11E3/uL ) Abnormal eGFR (<60 mL/min/1.73m2) Elevated IgE level above 50 IU/mL
- Subjects planning to undergo Elective procedures or surgeries at any time after signing the ICF through the follow-up visit.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- Recent history of bleeding or bleeding disorders or any condition whereby in the opinion of the treating investigator giving anti-coagulation during treatment would be contraindicated.
- History of hypersensitivity to antihistamines.
- Weight is over 350lbs.
- Subjects with active drug or alcohol abuse within 1 year prior to screening
- Subject is participating in a clinical trial of another investigational drug or device, including subjects who have participated in another study for a duration of 5 half-lives of the investigational agent.
- Investigators could exclude subjects with any medical condition, including, but not limited to, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or a psychiatric condition that, in the opinion of the Investigator, could compromise the participant's ability to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a/1b Study of OPT101 in Healthy Volunteers
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
Read the detailed description
2 part study description:
- an initial Phase 1a single ascending dose (SAD) phase to identify a safe dose of OPT101.
Dose escalation will be by a factor of 2.6: 0.16, 0.42, 1.1, 2.8 and 7.3mg/kg.
- a Phase 1b multiple ascending dose (MAD) phase to measure safety and clinical effects of the highest and next to highest dose of OPT101 that are found to be safe in Phase 1a.
- Conditions
- Healthy
- Being tested
- OPT101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT101Drug
Also called 15-mer peptide
15-mer peptide with sequence based on the mouse CD154 domain interacting with CD40
| Study group | Role | What they receive |
|---|---|---|
| 0.9% Sodium Chloride Injection USP | Placebo comparator | Placebo will be 50 mL normal saline (Sodium Chloride), USP sterile solution administered by IV infusion over 30 minutes. Receives: Drug: OPT101 |
| OPT101 | Experimental | The starting dose for the Phase 1a study is 0.16 mg/kg, which is 35-fold lower than the dog NOAEL (10mg/kg), on a mg/m2 basis. The dosing frequency for the MAD study was selected based on dosing performed in the supporting animal model studies. For an additional safety factor, the dose and volume infusion rates for the 0.16 mg/kg dose in humans will be 67-fold and 14-fold lower than the dogs dosed at 10mg/kg/min and mL/kg/min basis, respectively. For both Phase 1a and 1b, OPT101 will be administered by a slow IV infusion over 30 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 (Safety and Tolerability)
Incidence of abnormal vital signs and abnormal laboratory values
Measured: 21 days
Rate and type of adverse events during and after infusion of OPT101 or placebo
Collection of all adverse events
Measured: 48 hours
Incidence of vital signs
Continuous telemetry monitoring
Measured: 48 hours
Incidence of abnormal laboratory values
Blood laboratory results and iStat results onsite
Measured: 21 days
Definition of maximum tolerated (MTD) single and repeated doses of OPT101
DMC and Safety and Tolerability
Measured: 48 hours
Secondary outcomes (2)
Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2)
PK samples will be taken at 8 time points during the infusion
Measured: 8 hours
Development of anti-drug antibodies after 1 or more infusions
Anti-drug antibodies will be collected 2 times during study
Measured: 2 weeks- 1 prior to infusion and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start18 Feb 2021
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sentinel dosing of two subjects followed by review of the data by the Data Monitoring Committee (DMC) will be performed prior to enrolling any additional subjects within a cohort. Groups of 3 subjects (2 active:1 placebo) each will be treated at each dose level; for a total of 15 subjects. Additional subjects may be added to any cohort if dose limiting toxicity (DLT) is observed for a maximum of up to 6 subjects per cohort. An additional 6 subjects may also be enrolled in an intermediate dose cohort between the dose level which exceeds the defined MTD and the previous defined dose level.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Op-T LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isaac Melamed, MD, Principal investigator, IMMUNOe Health Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589403
- Sponsor's protocol ID
- OPT-100-30
- Status last verified
- Sep 2025
- First submitted
- 5 Oct 2020
- 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 1a/1b Study of OPT101 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04589403
- Acronym / sponsor ID
- OPT-100-30
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Op-T LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 19 Oct 2020 (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.
This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
Detailed description
2 part study description:
- an initial Phase 1a single ascending dose (SAD) phase to identify a safe dose of OPT101.
Dose escalation will be by a factor of 2.6: 0.16, 0.42, 1.1, 2.8 and 7.3mg/kg.
- a Phase 1b multiple ascending dose (MAD) phase to measure safety and clinical effects of the highest and next to highest dose of OPT101 that are found to be safe in Phase 1a.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Sentinel dosing of two subjects followed by review of the data by the Data Monitoring Committee (DMC) will be performed prior to enrolling any additional subjects within a cohort. Groups of 3 subjects (2 active:1 placebo) each will be treated at each dose level; for a total of 15 subjects. Additional subjects may be added to any cohort if dose limiting toxicity (DLT) is observed for a maximum of up to 6 subjects per cohort. An additional 6 subjects may also be enrolled in an intermediate dose cohort between the dose level which exceeds the defined MTD and the previous defined dose level.
| Arm | Type | Receives |
|---|---|---|
| 0.9% Sodium Chloride Injection USP | Placebo comparator | Drug: OPT101Placebo will be 50 mL normal saline (Sodium Chloride), USP sterile solution administered by IV infusion over 30 minutes. |
| OPT101 | Experimental | Drug: OPT101The starting dose for the Phase 1a study is 0.16 mg/kg, which is 35-fold lower than the dog NOAEL (10mg/kg), on a mg/m2 basis. The dosing frequency for the MAD study was selected based on dosing performed in the supporting animal model studies. For an additional safety factor, the dose and volume infusion rates for the 0.16 mg/kg dose in humans will be 67-fold and 14-fold lower than the dogs dosed at 10mg/kg/min and mL/kg/min basis, respectively. For both Phase 1a and 1b, OPT101 will be administered by a slow IV infusion over 30 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able and willing to give informed consent for the trial
- Male or female aged ≥18 years on the day of signing informed consent
- Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening
- Women of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
- Women must agree to use one of the following methods of birth control for the duration of the clinical trial: systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
Key exclusion criteria (52 listed)
- Is over the age of 55 years old
- Positive COVID test at screening/baseline
- Has an active fever or has recently been exposed to a COVID-19 patient.
- Currently has or had a history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
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 |
|---|---|---|
| OPT101Also: 15-mer peptide15-mer peptide with sequence based on the mouse CD154 domain interacting with CD40 | Drug | 0.9% Sodium Chloride Injection USP, OPT101 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 21 days
Incidence of abnormal vital signs and abnormal laboratory values
Rate and type of adverse events during and after infusion of OPT101 or placebo
Time frame: 48 hours
Collection of all adverse events
Incidence of vital signs
Time frame: 48 hours
Continuous telemetry monitoring
Incidence of abnormal laboratory values
Time frame: 21 days
Blood laboratory results and iStat results onsite
Definition of maximum tolerated (MTD) single and repeated doses of OPT101
Time frame: 48 hours
DMC and Safety and Tolerability
2 secondary outcomes
Determine pharmacokinetic (PK) Parameters (AUC0-t, Cmax, CL/F, t1/2)
Time frame: 8 hours
Development of anti-drug antibodies after 1 or more infusions
Time frame: 2 weeks- 1 prior to infusion and day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
Isaac Melamed, MD principal investigator
IMMUNOe Health Centers
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 Healthy, 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 5 inclusion and 52 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 21 days). The study lists 5 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.