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

NCT03381586 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CA-ALT-803-03-17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

ALT-803; PK

Outcome Measures

Primary Outcomes (7)

• PK Profile - Half-life (t½)

  The period of time required for the concentration or amount of drug in the body to be reduced by one-half.

  Up to 192 hours

• PK Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)

  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.

  Up to 192 hours

• PK Profile - Apparent (Extravascular) Clearance (CL/F)

  apparent (extravascular) clearance (CL/F)

  Up to 192 hours

• PK Profile - Maximum Observed Concentration (Cmax)

  maximum observed concentration (Cmax)

  Up to 192 hours

• PK Profile - Time of the Observed Maximum Concentration (Tmax)

  time of the observed maximum concentration (Tmax)

  Up to 192 hours

• PK Profile - Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)

  area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)

  Up to 192 hours

• PK Profile - Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)

  area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)

  Up to 192 hours

Secondary Outcomes (1)

• Number of Adverse Events

  Up to 66 days

Study Arms (2)

Group A

EXPERIMENTAL

1.0 mg/ml ALT-803

Drug: ALT-803

Group B

EXPERIMENTAL

2.0 mg/ml ALT-803

Drug: ALT-803

Interventions

ALT-803 DRUG

Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL and subjects randomized to Group B will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Written Informed Consent
• 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.
• 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
• Body mass index (BMI) must be within the range of 18 to 28 kg/m2. Subjects must weigh between 50 and 100 kg (inclusive).
• 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
• Men and women, 18 - 65 years of age.
• 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.
• 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.
• 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.

You may not qualify if:

• Medical History and Concurrent Diseases
• A past medical history of clinically significant 12 lead EKG abnormalities
• Subjects with a history of interstitial lung disease and/or pneumonitis.
• HIV-positive.
• Significant illness within 2 weeks prior to dosing.
• Positive hepatitis C serology or active hepatitis B infection.
• 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.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• 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.
• Loss of ≥ 475 mL blood volume or blood donation transfusion of any blood product within 3 months prior to screening.
• 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
• 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.
• Exposure to any investigational drug or placebo within 3 months of first dose of study drug.
• Previous treatment or clinical trial participation with monoclonal antibody therapy.

Sponsors & Collaborators

• Altor BioScience: lead

Study Sites (1)

Quotient Sciences

Miami, Florida, 33126, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

ALT-803

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 22, 2017
• Study Start: December 27, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)