QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: ALT-803

Registration Number: NCT03381586

Lead Sponsor: Altor BioScience

Brief Summary: This is a single center, open-label, pharmacokinetic study of ALT-803 administered as a subQ injection to healthy volunteers.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.
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.
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

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.
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.
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
Sex and Reproductive Status a. Women who are pregnant or nursing.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	ALT-803	1.0 mg/ml ALT-803
Group B	ALT-803	2.0 mg/ml ALT-803

Primary Outcome Measures

Name	Time	Method
PK Profile - Half-life (t½)	Up to 192 hours	The period of time required for the concentration or amount of drug in the body to be reduced by one-half.
PK Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)	Up to 192 hours	Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration.
PK Profile - Apparent (Extravascular) Clearance (CL/F)	Up to 192 hours	apparent (extravascular) clearance (CL/F)
PK Profile - Maximum Observed Concentration (Cmax)	Up to 192 hours	maximum observed concentration (Cmax)
PK Profile - Time of the Observed Maximum Concentration (Tmax)	Up to 192 hours	time of the observed maximum concentration (Tmax)
PK Profile - Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)	Up to 192 hours	area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)
PK Profile - Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)	Up to 192 hours	area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	Up to 66 days	Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03