CompletedNCT03630627Updated Apr 24, 2020

A Phase I Study of SB26 in Healthy Volunteers

A Phase 1 interventional study of SB26 and Placebo in Healthy Volunteers, sponsored by Samsung Bioepis Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Apr 2020, 6 years 5 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 58
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 SB26.
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).
The subject has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis) in the 30 days prior to Screening.
The subject has an electrocardiogram (ECG) showing a clinically significant abnormality at Screening or Check-in (Day -1). Entry of any subject with an abnormal but not clinically significant ECG must be approved, and documented by signature of the Principal Investigator or a medically qualified sub-Investigator.
The subject's ECG has a QT interval with Fridericia correction method > 450 msec for male, > 470 msec for female or a PR interval outside the range 120 to 220 msec, confirmed on repeat testing within a maximum of 30 minutes, at Screening or Check-in (Day -1).
The subject has a sustained resting heart rate outside the range 40 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes, at Screening or Check-in (Day -1).
The subject has systolic blood pressure > 140 or \< 90 mmHg or a diastolic blood pressure > 90 or \< 50 mmHg at Screening or Check-in (Day -1). One repeat testing is allowed at Screening and Check-in (Day -1)
The subject has any other abnormal laboratory values at Screening or Check-in (Day -1), confirmed upon repeat testing, that suggest a clinically significant underlying disease per the Investigator.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 58 participants (actual)

Study arms

Experimental
SB26 for Part 1
SB26: various single doses, administered to various cohorts
Drug: SB26
Experimental
SB26 for Part 2
SB26: various multiple doses, administered to various cohorts
Drug: SB26
Placebo comparator
Placebo for Part 1
SB26 matching placebo: various single doses, administered to various cohorts
Drug: Placebo
Placebo comparator
Placebo for Part 2
SB26 matching placebo: various multiple doses, administered to various cohorts
Drug: Placebo

Interventions

DrugSB26
SB26 administered intravenously
Also known as: TAK-671
DrugPlacebo
Placebo administered intravenously
Also known as: SB26/TAK-671 matching placebo

What researchers measure

Primary outcomes

Incidence of TEAE
Experience at least 1 treatment-emergent adverse event
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Incidence of AE leading to discontinuation
Discontinue due to adverse event
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal hematology parameters
Meet the criteria for markedly abnormal hematology parameters. The following parameters will be analyzed: White blood cell, red blood cell, hemoglobin, platelet count.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal serum chemistry parameters
Meet the criteria for markedly abnormal serum chemistry parameters. The following parameters will be analyzed: Blood urea nitrogen, creatinine, total protein, albumin, alanine transaminase, aspartate transaminase.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal coagulation parameters
Meet the criteria for markedly abnormal coagulation parameters. The following parameters will be analyzed: Prothrombin time, activated partial thromboplastin time.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal urinalysis parameters
Meet the criteria for markedly abnormal urinalysis parameters. The following parameters will be analyzed: Protein, glucose, urobilinogen, bilirubin.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal blood pressure
Meet the criteria for markedly abnormal blood pressure. Systolic blood pressure (SBP), diastolic blood pressure (DBP) will be measured in a supine position after at least 5 minutes of rest.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal heart rate
Meet the criteria for markedly abnormal heart rate. It will be measured in a supine position after at least 5 minutes of rest.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal body temperature
Meet the criteria for markedly abnormal body temperature. It will be measured in a supine position after at least 5 minutes of rest.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Abnormal ECG
Meet the criteria for markedly abnormal 12-lead ECG parameter. QT interaval with Fridericia correction method (QTcF) value will be measured in a supine position after at least 10 minutes of rest.
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71

Secondary outcomes

Cmax
Maximum observed serum concentration
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
tmax
Time to reach Cmax
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
AUClast
Area under the curve from the time of dosing to the time of the last measurable concentration
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Vd
Volume of distribution
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
CL
Total body clearance
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
t1/2
Terminal half-life
Time frame: Part 1: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
AUCinf
Area under the curve from the time of dosing extrapolated to infinity
Time frame: Part 1: From Day 1 until Day 50
Accumulation index
Predicted using terminal rate constant and dosing interval
Time frame: Part 1: From Day 1 until Day 50
AUCtau
Area under the serum concentration-time curve over the dosing interval
Time frame: Part 2: From Day 1 until Day 71
Accumulation ratio
Calculated using systemic exposure at first dosing and last dosing
Time frame: Part 2: From Day 1 until Day 71
Cmin
Minimum observed concentration
Time frame: Part 2: From Day 1 until Day 71
Incidence of ADA
Incidence of anti-drug antibody
Time frame: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Titer of ADAs
Titer of anti-drug antibodies to SB26
Time frame: From Day 1 until Day 50; Part 2: From Day 1 until Day 71
Incidence of NAb
Incidence of neutralizing antibody to SB26
Time frame: From Day 1 until Day 50; Part 2: From Day 1 until Day 71

Study locations

1 site

PAREXEL International
Glendale, California 91206, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03630627
Lead sponsor: Samsung Bioepis Co., Ltd.
Responsible party: Sponsor
First posted: Aug 15, 2018
Start date: Aug 22, 2018
Primary completion: Apr 16, 2020
Completion: Apr 16, 2020
Last update: Apr 24, 2020

Study contacts

David Han, M.D.

principal investigator · California Clinical Trials Medical Group, a division of PAREXEL International

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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