HealthyPhase 1NCT03381586

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

A Phase 1 study testing ALT-803 in people with Healthy, run by Altor BioScience at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ALT-803
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 27 Dec 2017to 13 Mar 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
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.
Transfusion of blood or any blood product within 3 months prior to screening.
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
History of severe hypersensitivity reactions to other monoclonal antibodies.
Known history of clinically significant drug allergy at Screening or Baseline
Sex and Reproductive Status a. Women who are pregnant or nursing.

Trial locations and contacts

1 site in 1 country.

United States1 site

Quotient Sciences
Miami, Florida, 33126

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: ALT-803
Keywords: ALT-803, PK

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALT-803Drug
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.

Study groups in NCT03381586
Study group	Role	What they receive
Group A	Experimental	1.0 mg/ml ALT-803 Receives: Drug: ALT-803
Group B	Experimental	2.0 mg/ml ALT-803 Receives: Drug: ALT-803

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Up to 192 hours
PK Profile - Apparent (Extravascular) Clearance (CL/F)
apparent (extravascular) clearance (CL/F)
Measured: Up to 192 hours
PK Profile - Maximum Observed Concentration (Cmax)
maximum observed concentration (Cmax)
Measured: Up to 192 hours
PK Profile - Time of the Observed Maximum Concentration (Tmax)
time of the observed maximum concentration (Tmax)
Measured: 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)
Measured: 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)
Measured: Up to 192 hours

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 201713 Mar 2018

First posted22 Dec 2017
Study start27 Dec 2017
Primary completion13 Mar 2018
Study completion13 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03381586
Sponsor's protocol ID: CA-ALT-803-03-17
Status last verified: Mar 2025
First submitted: 5 Dec 2017
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803
ClinicalTrials.gov ID: NCT03381586
Acronym / sponsor ID: CA-ALT-803-03-17
Conditions: Healthy
Keywords: ALT-803, PK
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Altor BioScienceIndustry (pharma, biotech, devices)
Study start: 27 Dec 2017 (actual)
Primary completion: 13 Mar 2018 (actual)
Study completion: 13 Mar 2018 (actual)
First posted: 22 Dec 2017 (actual)
Results: Posted 24 Mar 2025

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: ALT-8031.0 mg/ml ALT-803
Group B	Experimental	Drug: ALT-8032.0 mg/ml ALT-803

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Signed Written Informed Consent
Study Population
Age and Reproductive Status

Key exclusion criteria (22 listed)

Medical History and Concurrent Diseases
Prohibited Treatments and/or Restricted Therapies
Allergies and Adverse Drug Reaction
Sex and Reproductive Status a. Women who are pregnant or nursing.

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
ALT-803Subjects 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.	Drug	Group A, Group B

Primary outcome

PK Profile - Half-life (t½)
Time frame: 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)
Time frame: 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)
Time frame: Up to 192 hours
apparent (extravascular) clearance (CL/F)
PK Profile - Maximum Observed Concentration (Cmax)
Time frame: Up to 192 hours
maximum observed concentration (Cmax)
PK Profile - Time of the Observed Maximum Concentration (Tmax)
Time frame: 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)
Time frame: 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)
Time frame: Up to 192 hours
area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)

1 secondary outcome

Number of Adverse Events
Time frame: Up to 66 days

Results and safety

Results posted to the registry on 24 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	10	7
Group B	10	7

Primary outcome: PK Profile - Half-life (t½)

Time frame: Up to 192 hours. Mean (Standard Deviation). Unit: Days

Measure	Group A n = 6	Group B n = 5
Period 1 (10 μg/kg)	1.07 (0.813)	0.55 (0.095)
Period 2 (20 μg/kg)	1.02 (0.758)	0.68 (0.236)

Primary outcome: PK Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)

Time frame: Up to 192 hours. Mean (Standard Deviation). Unit: mL/kg

Measure	Group A n = 6	Group B n = 5
Period 1 - 10 μg/kg	13900 (12000)	5360 (2790)
Period 2 - 20 μg/kg	15500 (13000)	11800 (8170)

Primary outcome: PK Profile - Apparent (Extravascular) Clearance (CL/F)

Time frame: Up to 192 hours. Mean (Standard Deviation). Unit: mL/day/kg

Measure	Group A n = 6	Group B n = 5
Period 1 - 10 µg/kg	8650 (5450)	6610 (2680)
Period 2 - 20 µg/kg	10500 (5430)	11000 (4440)

Primary outcome: PK Profile - Maximum Observed Concentration (Cmax)

Time frame: Up to 192 hours. Mean (Standard Deviation). Unit: pg/mL

Measure	Group A n = 10	Group B n = 10
Period 1 - 10 µg/kg	1150 (945)	1080 (902)
Period 2 - 20 µg/kg	1900 (1930)	1490 (921)

Population analysed: In Period 2, 3 participants in each arm dropped off the study. In Group A, the 1 additional participant was excluded from the analysis. Subject 0317-001-0020 samples were Not Calculated for Period 1, but they were calculated for Period 2. Hence, the number of subjects with samples was greater in Period 2 than in Period 1.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 66 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Group B	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 ALT-803 in people with Healthy, run by Altor BioScience 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 11 inclusion and 22 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 24 Mar 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. 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?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PK Profile - Half-life (t½) (time frame: Up to 192 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03381586.

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 24 Mar 2025.