A Phase1 Study of VIB9600

Amgen

Status and phase: Terminated; Phase 1

Conditions: Safety Issues

Treatments: Drug: Placebos; Biological: VIB9600

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03621605

VIB9600.P1.S1

Details and patient eligibility

About

Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

VIB9600

Experimental group

Description:

Single dose of VIB9600 administered by IV infusion or SC injection. Multiple dose VIB9600 administered by IV infusion every 2 weeks for 4 weeks.

Treatment:

Biological: VIB9600

Placebo

Placebo Comparator group

Description:

Placebo comparator administered by slow IV infusion or SC injection.

Treatment:

Drug: Placebos