A Phase1 Study of VIB9600

Phase 1

Terminated

• Conditions: Safety Issues
• Interventions: Drug: Placebos; Biological: VIB9600

• Registration Number: NCT03621605
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Study Start: 2018-08-14
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Placebo comparator administered by slow IV infusion or SC injection.
VIB9600	VIB9600	Single dose of VIB9600 administered by IV infusion or SC injection. Multiple dose VIB9600 administered by IV infusion every 2 weeks for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CTI Clinical Trial & Consulting Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States