CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
ALT-803drug
Likely dose
10 µg/kg subcutaneous single dose in two formulation groups (1.0 mg/mL and 2.0 mg/mL)AI-extracted
Key inclusion· 4
  • ✓Age 18-65 years
  • ✓BMI 18-28 kg/m² and weight 50-100 kg
  • ✓Good health as determined by medical history, physical examination, vital signs, and laboratory tests
  • ✓Female subjects of childbearing potential must use effective contraception and have negative pregnancy test <14 days prior to dosing
Key exclusion· 10
  • ✕Clinically significant EKG abnormalities
  • ✕History of interstitial lung disease and/or pneumonitis
  • ✕HIV-positive or positive hepatitis C serology or active hepatitis B infection
  • ✕Active autoimmune disease or requiring systemic corticosteroids >10 mg daily prednisone equivalent or immunosuppressive medications within 4 weeks or 5 half-lives

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03381586
NCT03381586Phase 1Completed
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QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803

Altor BioScience·interventional·Posted Dec 22, 2017·Updated Mar 24, 2025

In Brief

A Phase 1 clinical trial evaluating ALT-803 for Healthy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 22, 2017
Enrollment StartDec 27, 2017
Primary CompletionMar 13, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.5 years ago

Interventions

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.