QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/11/2018 |
Start Date: | January 8, 2018 |
End Date: | May 31, 2018 |
This is a single center, open-label, pharmacokinetic study of ALT-803 administered as a subQ
injection to healthy volunteers.
injection to healthy volunteers.
Inclusion Criteria:
1. Signed Written Informed Consent
1. Subjects must have signed and dated an IRB/IEC approved written informed consent
form in accordance with regulatory and institutional guidelines. This must be
obtained before the performance of any protocol related procedures that are not
part of subject care.
2. Subjects must be willing and able to comply with the scheduled visits, study drug
dosing schedule, procedures, laboratory tests, and other requirements of the
study.
2. Study Population
1. Body mass index (BMI) must be within the range of 18 to 28 kg/m2. Subjects must
weigh between 50 and 100 kg (inclusive).
2. Subjects must be in good health as determined by past medical history, complete
physical examination, vital signs and laboratory tests at screening.
3. Age and Reproductive Status
1. Men and women, 18 - 65 years of age.
2. Female participants of childbearing potential must adhere to using a medically
accepted method of birth control up to 28 days prior to screening and agree to
continue its use during the study or be surgically sterilized (e.g., hysterectomy
or tubal ligation) WOCBP must agree to use effective contraception during the
study and for at least 1 month following the last dose of the study drug.
3. WOCBP must have a negative serum pregnancy test < 14 days prior to first dose of
the study drug. Non-childbearing is defined as greater than one year
postmenopausal or surgically sterilized.
4. Male subjects must be willing to use barrier contraception (i.e. condoms and
spermicide) from the day of dosing until at least 1 month following the last dose
of study drug.
Exclusion Criteria:
1. Medical History and Concurrent Diseases
1. A past medical history of clinically significant 12 lead EKG abnormalities
2. Subjects with a history of interstitial lung disease and/or pneumonitis.
3. HIV-positive.
4. Significant illness within 2 weeks prior to dosing.
5. Positive hepatitis C serology or active hepatitis B infection.
6. Known autoimmune disease requiring active treatment. Subjects with a condition
requiring systemic treatment with either corticosteroids (>10 mg daily prednisone
equivalent) or other immunosuppressive medications within 4 weeks or 5 half-lives
of registration are excluded.
7. Psychiatric illness/social situations that would limit compliance with study
requirements.
8. Previous malignancies, unless basal or squamous cell carcinoma of the skin or
cervical carcinoma in situ with a complete remission achieved at least 5 years
prior to study entry and no additional therapy is required or anticipated to be
required during the study period.
9. Loss of ≥ 475 mL blood volume or blood donation transfusion of any blood product
within 3 months prior to screening.
10. Other illness or laboratory abnormality that in the opinion of the Investigator
should exclude the subject from participating in this study.
2. Prohibited Treatments and/or Restricted Therapies
1. Use of any prescription drugs within 4 weeks (hormonal methods of contraception
are allowed) or less than 5 half-lives prior to dosing, or over-the-counter (OTC)
medication (vitamins, herbal supplements, dietary supplements) within 2 weeks or
less than 5 half-lives prior to dosing.
2. Exposure to any investigational drug or placebo within 3 months of first dose of
study drug.
3. Previous treatment or clinical trial participation with monoclonal antibody
therapy.
4. History of drug or alcohol abuse within 12 months prior to dosing, or those who
have a positive urine drug test or breath alcohol test at Screening or Baseline.
5. Transfusion of blood or any blood product within 3 months prior to screening.
6. History of using nicotine-containing products or smoking more than 5 cigarettes
weekly for at least three months prior to the study through the final evaluation.
3. Allergies and Adverse Drug Reaction
1. History of severe hypersensitivity reactions to other monoclonal antibodies.
2. Known history of clinically significant drug allergy at Screening or Baseline
4. Sex and Reproductive Status a. Women who are pregnant or nursing.
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