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A First-time-in-human Study of BGB149

NCT03795142 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-03-16

No results posted yet for this study

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

Interventions

BIOLOGICAL

BGB149

Single Ascending Dose

BIOLOGICAL

Placebo

Matching placebo

Sponsors & Collaborators

  • BerGenBio ASA

    lead INDUSTRY

Principal Investigators

  • Muna Albayaty, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795142 on ClinicalTrials.gov