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ALS-002200

Phase 1

Hepatitis C, Chronic | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Oct 31, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

ALS-002200 · 1 trial · 1 indication

Phase 1 1
NCT01590407First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1Hepatitis C, Chronic
COMPLETED71 Analytics
PHASE1COMPLETED
First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
Hepatitis C, Chronic
NCT0159040771
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Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
up to Day 31

data points measured include patient reported adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results

Secondary Endpoints

Cmax
pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
AUC
pre-dose and 0.25, 0.5, 1, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
HCV ribonucleic acid (RNA) viral load reduction
Baseline to Day 31
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALS-002200EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALS-002200DRUGALS-002200
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Subject has provided written consent. * In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned. * Subject is in good health as deemed ...

Countries:FranceMoldovaRomania
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Frequently asked questions about ALS-002200

What is ALS-002200 used for?

ALS-002200 is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It is currently in Phase 1 clinical development and has been studied in a first-in-human trial that included healthy volunteers and patients with chronic Hepatitis C genotype 1.

What does ALS-002200 target?

ALS-002200 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available information. It is being studied for its potential to treat chronic Hepatitis C infection.

Who makes ALS-002200?

ALS-002200 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating chronic Hepatitis C.

What phase is ALS-002200 in?

ALS-002200 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains under investigation for the treatment of chronic Hepatitis C.

What clinical trials is ALS-002200 in?

ALS-002200 has been studied in one completed Phase 1 clinical trial with the identifier NCT01590407. This first-in-human study evaluated single doses, food effects in healthy volunteers, and multiple doses in patients with chronic Hepatitis C genotype 1. The trial enrolled 71 participants across France, Moldova, and Romania.

Is ALS-002200 the same as other Hepatitis C drugs?

ALS-002200 is a distinct investigational small molecule developed by Vertex Pharmaceuticals. It is not known to be the same as any other marketed Hepatitis C drug. Its mechanism of action and chemical structure have not been publicly detailed in the available information.