Safety Issues
Conditions
Brief summary
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
Detailed description
This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600. Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Interventions
BIOLOGICALVIB9600
Part 1 (SAD): IV infusion (30, 100, 200, 300 or 1000 mg) or SC injection (300 mg) on Day 1. Part 2 (MAD): IV infusion (100 and 300 mg) every 2 weeks for 4 weeks (3 doses total; Days 1, 15 and 29).
DRUGPlacebos
Placebo administered by slow IV infusion or SC injection.
Sponsors
CTI Clinical Trial and Consulting Services
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Investigator and subject are blinded, sponsor and site pharmacist are unblinded.
Intervention model description
A minimum of 56 subjects will be enrolled in 7 planned SAD cohorts (8 subjects per cohort). Subjects enrolled in SAD cohorts will be admitted to a Phase 1 unit and randomized to receive a single dose of VIB9600 or placebo administered by slow IV infusion or SC injection. A minimum of 16 subjects will be enrolled in 2 planned MAD cohorts (8 subjects per cohort). Subjects enrolled in the MAD cohorts will receive VIB9600 or placebo Q2W for 4 weeks (3 doses in total: one each on Days 1, 15 and 29).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Healthy male and female subjects aged 18 through 65 years at the time of consent. 2. Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg. 3. Females must have been surgically sterilized. 4. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through to the final follow-up visit. 5. Able and willing to comply with the requirements of the protocol. Key
Exclusion criteria
1. Concurrent enrollment in another clinical study involving an investigational treatment. 2. Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1). 3. Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned. 4. History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening. 5. Positive test for drugs of abuse. 6. Donation of blood or blood products in excess of 500 mL within 3 months prior to screening. Not agreeing to refrain from blood or blood product donations during study participation. 7. Receiving any of the prohibited concomitant medications: 1. Any immunotherapy or immunosuppressive therapy 2. Chronic use of steroid medications 3. Immunoglobulin or blood products 4. Live vaccines 5. Anticoagulants 6. Aspirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of single and multiple doses of VIB9600 | 113 days | Treatment-emergent adverse events that occur on or after the day of IP administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK of VIB9600 following single- and multiple- dose administration | SAD- Days 1, 2, 3, 5, 8, 16, 29, 43, 57, 85, 113; MAD- Days 1, 3, 8, 15, 22, 29, 32, 36, 43, 57, 86, 113 | Concentration of VIB9600 in serum at different time points after IP administration. |
| Immunogenicity of VIB9600 following single- and multiple-dose administration. | SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113 | Immunogenicity as measured by the presence of anti-drug antibodies (ADA) to VIB9600 |
Countries
United States
Outcome results
None listed