A First-time-in-human Study of BGB149

NCT03795142 | Completed Early Phase 1 DMC

• 1 other identifier: BGB149-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a Phase I, first-in-human. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of BGB149 after single IV doses in healthy male and female subjects. Multiple dose levels will be explored.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent clinical adverse events (AE) following single intravenous (IV) administration of BGB149 or matched placebo

  Number of healthy volunteers experiencing adverse events (AE) AE categorized by grading for severity according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0).

  85 days

• Frequency of treatment-emergent laboratory abnormalities following single intravenous (IV) administration of BGB149 or matched placebo

  Number of healthy volunteers experiencing clinically significant abnormalities of clinical laboratory tests (hematology, coagulation, clinical chemistry and urinalysis); categorized by grading for severity according to the CTCAE version 5.0.

  85 days

Secondary Outcomes (10)

• Pharmacokinetic Parameters: BGB149 Cmax following single intravenous (IV) administration of BGB149 or matched placebo

  85 days

• Pharmacokinetic Parameters: BGB149 Tmax following single intravenous (IV) administration of BGB149 or matched placebo

  85 days

• Pharmacokinetic Parameters: BGB149 AUC(0-last), following single intravenous (IV) administration of BGB149 or matched placebo

  up to 85 days

• Pharmacokinetic Parameters: BGB149 AUC(0-infinity) following single intravenous (IV) administration of BGB149 or matched placebo

  85 days

• Pharmacokinetic Parameters: BGB149 terminal elimination rate constant λz, following single intravenous (IV) administration of BGB149 or matched placebo

  85 days

Study Arms (2)

single intravenous dose; BGB149

EXPERIMENTAL

A single intravenous dose of BGB 149 or matched placebo will be administered on day 1 ascending doses will be administered in cohorts of 6 (randomised 4:2, active: placebo) at a planned four dose levels (maximum of six dose levels to be investigated under initial approved protocol) A sentinel cohort of 2 volunteers will randomly receive (1:1) either experimental or matched placebo infusion

Biological: BGB149

single intravenous dose; placebo

PLACEBO COMPARATOR

A single intravenous dose of BGB 149 or matched placebo will be administered on day 1 ascending doses will be administered in cohorts of 6 (randomised 4:2, active: placebo) at a planned four dose levels (maximum of six dose levels to be investigated under initial approved protocol) A sentinel cohort of 2 volunteers will randomly receive (1:1) either experimental or matched placebo infusion

Biological: Placebo

Interventions

BGB149 BIOLOGICAL

Single Ascending Dose

single intravenous dose; BGB149

Placebo BIOLOGICAL

Matching placebo

single intravenous dose; placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee approved informed consent form prior to performing any of the screening procedures.
• Healthy male and female subjects, between 18 to 55 years of age, inclusive, at the screening visit.
• If male, Must agree to use appropriate double-barrier contraception and to refrain from donating sperm from the time of dosing until 3 months after dosing.
• If female, Must be of non-childbearing potential (surgically sterile \[hysterectomy or bilateral tubal ligation\] or postmenopausal ≥ 1 year with follicle stimulating hormone \> 40 IU/L).
• Body mass index between 18.0 and 30.0 kg/m2, inclusive, at the screening visit with a weight of at least 50kg.
• Non-smoker, defined as a subject who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products (including snuff and similar products) at least 3 months before the screening visit.
• Subjects are in good health, as determined by medical history, physical examination, vital signs assessment, resting 12-lead ECG and clinical laboratory evaluations within normal reference ranges or outside of normal reference ranges considered not clinically relevant by the Principal Investigator or designee.
• Subject must have suitable veins for cannulation and/or repeated venipuncture.

You may not qualify if:

• Female subjects of childbearing potential, or breastfeeding, or have a positive serum pregnancy test at the screening visit or a positive urine pregnancy test on admission.
• A positive urine cotinine result (\>500ng/mL) at the screening visit or on admission.
• Subjects who have ongoing or significant history of alcoholism or drug/chemical abuse in the past 5years, as determined by the Principal Investigator or designee.
• Subjects who have positive urine drugs of abuse screen at the screening visit or on admission, or a positive urine alcohol test at the screening visit or on admission.
• Subjects who are unwilling to avoid the use of alcohol within 48 hours before any study visit and while confined to the study center.
• Subjects who are unwilling to abstain from heavy physical training from 7 days before first dosing until the final follow-up visit.
• Subjects who have used the following: Any prescribed medication within 14 days prior to planned time of dosing. Non-prescription or over-the-counter medication, herbal and dietary supplements such as St John's Wort, vitamins and minerals that could affect the outcome of the study within 1 week prior to planned time of dosing. Live attenuated vaccines and systemic corticosteroids within 3 months prior to planned time of dosing.
• Subjects who have donated blood in the 3 months prior to the screening visit, plasma in the 7 days prior to the screening visit or platelets in the 6 weeks prior to the screening visit.
• Subjects who have a history of significant drug allergy (e.g., anaphylaxis) or any clinically significant allergic condition (excluding non-active hay fever), as determined by the Principal Investigator or designee.
• Subjects who have had a clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing, as determined by the Principal Investigator or designee.
• Subjects with history of gastrointestinal bleeding or ulceration or perforation; history of Crohn's disease or any other inflammatory disorder of the gastrointestinal tract.
• Subjects with history of bone marrow transplant, with or without graft versus host disease.
• Subjects who have pulse, blood pressure, respiratory rate or oral body temperature values outside the normal ranges at the screening visit or on admission that is, in the opinion of the Principal Investigator or designee, clinically relevant and increases the risk of participating in the study.
• Results of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and/or total bilirubin (TBL) above the upper limit of normal (ULN), as confirmed by subsequent repeat assessment, at the screening visit and on admission.
• A positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or antibodies to human immunodeficiency virus (HIV) Type 1 and/or Type 2 at the screening visit.

Sponsors & Collaborators

• BerGenBio ASA: lead

Study Sites (1)

Parexel Northwick Park

London, Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Study Officials

• Muna Albayaty, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical study will be performed in a double-blinded manner for all cohorts.
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: January 7, 2019
• Study Start: December 19, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)