A Randomized, Double-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Explore the Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of SB26 in Healthy Volunteers

Samsung Bioepis Co., Ltd.1 site in 1 country58 target enrollmentAugust 22, 2018

ConditionsHealthy Volunteers

InterventionsSB26 Placebo

DrugsSB26 Placebo

Overview

Phase: Phase 1
Intervention: SB26
Conditions: Healthy Volunteers
Sponsor: Samsung Bioepis Co., Ltd.
Enrollment: 58
Locations: 1
Primary Endpoint: Incidence of TEAE
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a Phase I, randomized double-blind, placebo-controlled (within a dose group), single and multiple rising dose study of the intravenous administration of SB26 in healthy volunteers.

Detailed Description

The study includes two Parts; Part 1 includes the FiH exposure and SRD and Part 2 is the MRD. Approximately 58 subjects will be enrolled in the study. New subjects will be recruited for each cohort in both Parts. The SRD Part will include 5 or more dose levels and the MRD Part will include 3 or more dose levels; additional dose level(s) may be added based on emerging safety and PK data from prior cohorts.

Registry

clinicaltrials.gov

Start Date

August 22, 2018

End Date

April 16, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Bioepis Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
•The subject signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
•The subject is willing to comply with study procedures and restrictions.
•The subject is a healthy adult man or woman of non-childbearing potential.
•The subject is aged 18 to 65 years, inclusive, at the time of informed consent.
•The subject weighs at least 50 kg and has a body mass index from 18 to 32 kg/m2, inclusive, at Screening.
•If the subject is a male who is non-sterilized and who is sexually active with a female partner of childbearing potential, agrees to use adequate contraception from signing of ICF throughout the duration of the study until 60 days (i.e., estimated \> 5 half-lives) after the last dose of study drug(s).
•The subject is a non-smoker or ex-smoker who has not used tobacco- or nicotine-containing products (e.g., nicotine patch) for at least 6 months prior to first administration of study drug (Day 1) and who has had a negative urine cotinine at Screening and Check-in (Day -1).

Exclusion Criteria

•The subject has received any investigational compound or medication within 30 days or five half-lives, whichever is the longest, prior to the first intended dose of study drug.
•The subject is a study site employee, immediate family member thereof, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, or sibling) or may consent under duress.
•The subject has a known hypersensitivity to any component of the formulation of SB26, or has had clinically significant infusion-related reactions to any prior biologic drug unless it can be established that the reaction was due to components not present in the formulation of SB
•The subject has a positive urine result for drugs of abuse at Screening or Check-in (Day -1).
•The subject has a history of drug abuse or a history of alcohol abuse (defined as drinking alcoholic beverages of more than 21 units per week for males and 14 units per week for females; 1 unit = 14 g of pure alcohol, e.g., 1 unit = 250 mL of beer, 25 mL of spirits or one glass \[125 mL\] of wine) within 1 year prior to Screening.
•If male, the subject intends to father a child or to donate sperm during the course of this study until 60 days after the last dose of study drug.
•The subject has evidence of current or recent (within 6 months prior to Screening) disease that, in the opinion of the Investigator, may pose additional risks to the subject or confound the assessment of safety and tolerability. This should be discussed with the Sponsor's medical representative if there is uncertainty about the suitability of the subject.
•The subject has a history of cancer, except basal cell carcinoma or cervical carcinoma in situ that has been treated and in remission for at least 5 years prior to Screening.
•The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus at Screening.
•The subject has poor peripheral venous access at Screening or Check in (Day -1).

Arms & Interventions

SB26 for Part 1

SB26: various single doses, administered to various cohorts

Intervention: SB26

SB26 for Part 2

SB26: various multiple doses, administered to various cohorts

Intervention: SB26

Placebo for Part 1

SB26 matching placebo: various single doses, administered to various cohorts

Intervention: Placebo

Placebo for Part 2

SB26 matching placebo: various multiple doses, administered to various cohorts

Intervention: Placebo