Clinical trial NCT03621605: A Phase1 Study of VIB9600
Official title: A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of VIB9600 by Intravenous Infusion or Subcutaneous Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2018-08-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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).
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability of single and multiple doses of VIB9600
timeFrame: 113 days
Secondary outcomes:
measure: PK of VIB9600 following single- and multiple- dose administration
timeFrame: 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
measure: Immunogenicity of VIB9600 following single- and multiple-dose administration.
timeFrame: SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: CTI Clinical Trial & Consulting Clinical Research Center
state: Ohio
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
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