MassBiologics: Clinical Trials

4 completed, 2 terminated. 3 Phase 1, 3 Phase 2.

By phase and status

Phase	Trials	Status
Phase 1	3	Completed 3
Phase 2	3	Terminated 2, Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People 2217LS, 0.9% Sodium Chloride (NaCl) - Lyme Disease	Phase 1	Completed	MassBiologics	44	2021-02-11	2022-09-16
Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects S315, 0.9% Sodium Chloride (NaCl) - Diphtheria	Phase 1	Completed	MassBiologics	41	2019-04-23	2020-02-05
Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C MBL-HCV1, Telaprevir (Part 1), Sofosbuvir (Part 2) - Hepatitis C Infection	Phase 2	Terminated	MassBiologics	11	2012-11-21	2021-02-05
Study in Hepatitis C Virus (HCV) Infected Patients Undergoing Liver Transplantation to Evaluate a Human Monoclonal Antibody Against Hepatitis C MBL-HCV1, 0.9% Sodium chloride Placebo - HCV Infection, Liver Transplantation	Phase 2	Terminated	MassBiologics	13	2010-06-01	2016-06-14
Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C MBL-HCV1 - Healthy	Phase 1	Completed	MassBiologics	31	2009-07-01	2016-09-15
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease GS-CDA1/MDX-1388, normal saline - Clostridium Infections	Phase 2	Completed	MassBiologics	200	2006-07-20	2021-02-09

Conditions studied

Hepatitis C (3)  ·  Clostridium Infections (1)  ·  Diphtheria (1)  ·  Lyme Disease (1)

Interventions

Saline Solution (2)  ·  Sodium Chloride (2)  ·  Sofosbuvir (1)  ·  telaprevir (1)

Countries

United States (6)  ·  Canada (1)

Top investigators

Alfred Bacon, MD (1)  ·  Andre Poirier, MD, MSc (1)  ·  Anil Dhar, MBBS (1)  ·  Ann Silverman, MD (1)  ·  C. Douglas Cochran, MD (1)  ·  Charles N. Bernstein, MD (1)  ·  Daniel Schroeder, MD (1)  ·  Darrell Pardi, MD (1)  ·  David Chen, MD (1)  ·  Deborah C. Molrine, MD (1)  ·  Donald Daly, MD (1)  ·  Doria Grimard, MD (1)  ·  Gerald Evans, MD (1)  ·  Henry S. Sacks, MD, PhD (1)  ·  Herbert DuPont, MD (1)

Results publications

PMID 20089970, PMID 23356386, PMID 27365387, PMID 31411386, PMID 39570031