A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2013-001983-52-GB
• Date of registration: 19/09/2013
• Prospective Registration: Yes
• Primary sponsor: Genentech Inc.
• Public title: A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model
• Scientific title: A randomized, double-blind, placebo-controlled, phase 2a study in healthy volunteers, to evaluate the efficacy and safety of MHAA4549A in an Influenza challenge model
• Date of first enrolment: 19/09/2013
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001983-52
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Influenza challenge study If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: GENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: GENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests
- Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit
- Sero-suitable for challenge virus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study
- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI
- Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry
- History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment.
- History suggestive of respiratory infection within 14 days prior to admission to the unit


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of Influenza
MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862
MedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862
MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: MHAA4549A
Product Code: MHAA4549A/RO6876802
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: MHAA4549A/RO6876802
Other descriptive name: [anti-Influenza A, 39.29]
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Tamiflu
Pharmaceutical Form: Capsule, hard
CAS Number: 204255-11-8
Other descriptive name: OSELTAMIVIR PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 8 days

Primary end point(s): Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)

Main Objective: To evaluate the reduction in AUC of virus load from the nasopharyngeal mucosa in the MHAA4549A treatment group compared to placebo

Secondary Objective: To evaluate safety, efficacy and pharmacokinetics

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) 120 days
2) from pre-challenge to Day 29
3) 120 days
4) 8 days
5) 8 days
6) 8 days
7) 8 days

Secondary end point(s): 1) Safety: Incidence of adverse events
2) Safety: Change in lung function
3) Safety: Incidence of anti-therapeutic antibodies (ATAs)
4) Pharmacokinetics: Area under the concentration-time curve
5) AUC of nasopharyngeal viral load, as measured by cell culture
6) Peak viral load (qPCR and cell culture)
7) Duration of viral shedding

Secondary ID(s)

GV28985

Source(s) of Monetary Support

GENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 04/03/2016
• Date Completed: 19/06/2014
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001983-52/results