A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects
| Registry | NCT03267732, acronym Willow 1 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 24 (Actual) |
| Sponsor | Eli Lilly and Company (Industry); collaborators: ARMO BioSciences |
| Conditions | Healthy Adult Subjects |
| Interventions | Pegilodecakin (Biological) |
| Dates | start 2017-09-05, primary completion 2017-10-17, completion 2017-10-17, first posted 2017-08-30, last updated 2026-10-02 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Healthy Adult Subjects All trials of Pegilodecakin
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
This is an open-label, randomized, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pegilodecakin (5 μg/kg) | Experimental | Biological: Pegilodecakin | 5 microgram per kilogram (μg/kg) of pegilodecakin was administered as subcutaneous injection. Flat dosing was used with 2 weight-banded dose levels based on body weight (ie, either 400 μg for participants who weighed 80 kg or less and 800 μg for participants who weighed greater than 80 kg). |
| Pegilodecakin (10 μg/kg) | Experimental | Biological: Pegilodecakin | 10 μg/kg of pegilodecakin was administered as subcutaneous injection. Flat dosing was used with 2 weight-banded dose levels based on body weight (ie, either 800 μg for participants who weighed 80 kg or less and 1600 μg for participants who weighed greater than 80 kg). |
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
Inclusion Criteria: 1. Male or female between 18 and 55 years of age, inclusive 2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening 3. Must be HIV negative by HIV 1/0/2 testing 4. Must be Hepatitis B (HBV) surface antigen negative 5. Must be Hepatitis C (HCV) antibody negative 6. Females must have a negative serum pregnancy test 7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug Exclusion Criteria: 1. Pregnant or lactating subjects 2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing 3. Have poor venous access and are unable to donate blood 4. Have been vaccinated within 90 days of study dosing 5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance 6. Have history of significant drug sensitivity or drug allergy.
| Milestone | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| Started | 12 | 12 |
| Received at least 1 dose of study drug | 12 | 12 |
| Completed | 11 | 11 |
| Not completed | 1 | 1 |
Time frame: Baseline Up To 43 Days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Pegilodecakin (5 μg/kg) | 0/12 (0.0%) | 0/12 (0.0%) | 11/12 (91.7%) |
| Pegilodecakin (10 μg/kg) | 0/12 (0.0%) | 0/12 (0.0%) | 11/12 (91.7%) |
| Term | Organ system | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | 1/12 | 0/12 |
| Abdominal discomfort | Gastrointestinal disorders | 0/12 | 1/12 |
| Nausea | Gastrointestinal disorders | 0/12 | 3/12 |
| Asthenia | General disorders | 0/12 | 1/12 |
| Chills | General disorders | 1/12 | 1/12 |
| Fatigue | General disorders | 0/12 | 1/12 |
| Hunger | General disorders | 0/12 | 1/12 |
| Injection site erythema | General disorders | 9/12 | 11/12 |
| Injection site lymphadenopathy | General disorders | 4/12 | 4/12 |
| Injection site nodule | General disorders | 1/12 | 0/12 |
| Injection site pain | General disorders | 0/12 | 3/12 |
| Injection site pruritus | General disorders | 5/12 | 6/12 |
| Medical device site dermatitis | General disorders | 0/12 | 1/12 |
| Pyrexia | General disorders | 3/12 | 5/12 |
| Nasopharyngitis | Infections and infestations | 2/12 | 0/12 |
| Oral herpes | Infections and infestations | 1/12 | 0/12 |
| Tooth fracture | Injury, poisoning and procedural complications | 0/12 | 1/12 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0/12 | 1/12 |
| Back pain | Musculoskeletal and connective tissue disorders | 1/12 | 0/12 |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 0/12 | 1/12 |
| Myalgia | Musculoskeletal and connective tissue disorders | 3/12 | 5/12 |
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | 0/12 | 1/12 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 0/12 | 1/12 |
| Dizziness | Nervous system disorders | 1/12 | 1/12 |
| Headache | Nervous system disorders | 7/12 | 8/12 |
| Syncope | Nervous system disorders | 0/12 | 1/12 |
| Tremor | Nervous system disorders | 0/12 | 1/12 |
| Chromaturia | Renal and urinary disorders | 1/12 | 0/12 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1/12 | 1/12 |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 0/12 | 1/12 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0/12 | 1/12 |
| Erythema | Skin and subcutaneous tissue disorders | 0/12 | 1/12 |
| Papule | Skin and subcutaneous tissue disorders | 0/12 | 1/12 |
| Pruritus | Skin and subcutaneous tissue disorders | 0/12 | 1/12 |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | 0/12 | 1/12 |
| Facility | City | Country | Status |
|---|---|---|---|
| PPD Development | Austin, Texas | United States |