CLINICAL TRIALS PROFILE FOR LANINAMIVIR

Clinical Trials for Laninamivir

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00995826 ↗	Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	The purpose of this study is to test the safety and tolerability of an investigational multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication), once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks. Study procedures will include blood and urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed as well as physical examinations and spirometry assessments.
NCT00995826 ↗	Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958	Completed	Biota Scientific Management Pty Ltd	Phase 1	The purpose of this study is to test the safety and tolerability of an investigational multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication), once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks. Study procedures will include blood and urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed as well as physical examinations and spirometry assessments.
NCT01793883 ↗	Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza	Completed	Department of Health and Human Services	Phase 2	This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.
NCT01793883 ↗	Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza	Completed	Biota Scientific Management Pty Ltd	Phase 2	This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.
NCT02014649 ↗	Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza	Terminated	Department of Health and Human Services	Phase 1/Phase 2	This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
NCT02014649 ↗	Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza	Terminated	Biota Scientific Management Pty Ltd	Phase 1/Phase 2	This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.

Clinical Trial Conditions for Laninamivir

Condition Name

Condition Name
Intervention	Trials
Influenza	4
Asthma	1
Influenza, Human	1

Condition MeSH

Condition MeSH
Intervention	Trials
Influenza, Human	3
Asthma	1

Clinical Trial Locations for Laninamivir

Trials by Country

Trials by Country
Location	Trials
United States	46
United Kingdom	9
South Africa	7
France	5
Germany	5

Trials by US State

Trials by US State
Location	Trials
California	2
Arkansas	2
Arizona	2
Utah	2
Texas	2

Clinical Trial Progress for Laninamivir

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	2
Phase 1/Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Not yet recruiting	1

Clinical Trial Sponsors for Laninamivir

Sponsor Name

Sponsor Name
Sponsor	Trials
Biota Scientific Management Pty Ltd	4
Department of Health and Human Services	3
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	4
U.S. Fed	3
NIH	1