This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blinded study that will be conducted in 2 parts.
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.
Drug: OPT101
15-mer peptide with sequence based on the mouse CD154 domain interacting with CD40
Other Name: 15-mer peptide
Inclusion :
- 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.
Exclusion:
- 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 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.
Exclusion:
- 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.
IMMUNOe Research
Centennial, Colorado, United States
Isaac Melamed, MD, Principal Investigator
IMMUNOe Health Centers