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ALXN1007

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 3, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

ALXN1007 · 2 trials · 2 indications

Phase 1 2
NCT01883544Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female SubjectsHealthy Subjects
COMPLETED16 Analytics
NCT01454986Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy SubjectsHealthy
COMPLETED64 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects
Healthy Subjects
NCT0188354416
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PHASE1COMPLETED
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
Healthy
NCT0145498664
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Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of multiple, IV doses of ALXN1007 in healthy male and female subjects as assessed by physical exam, vital signs, electrocardiogram (ECG), immunogenicity, laboratory analysis, and assessment of adverse events (AEs
90 days follow-up
Safety and tolerability of a single dose of ALXN1007.
Up to 90 days

Safety and tolerability of a single dose of ALXN1007 assessed by physical exam, vital signs, ECG, immunogenicity, lab analysis and adverse events.

Secondary Endpoints

PK parameters of ALXN1007
Up to 90 days
PD parameters of ALXN1007
Up to 90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALXN1007EXPERIMENTALInfusion of ALXN1007
placeboPLACEBO_COMPARATORInfusion placebo
Cohort 1ACTIVE_COMPARATOR0.06 mg/kg ALXN1007
Cohort 2ACTIVE_COMPARATOR0.1 mg/kg ALXN1007
Cohort 3ACTIVE_COMPARATOR0.3 mg/kg ALXN1007
Cohort 4ACTIVE_COMPARATOR1.0 mg/kg ALXN1007
Cohort 5ACTIVE_COMPARATOR3.0 mg/kg ALXN1007
Cohort 6ACTIVE_COMPARATOR6.0 mg/kg ALXN1007
Cohort 7ACTIVE_COMPARATOR10.0 mg/kg ALXN1007

Interventions

NameTypeDescription
ALXN1007DRUG -
PlaceboOTHERSingle dose, IV
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Eligibility Criteria

Age Range25 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy male or female (not of childbearing potential) subjects ≥25 and ≤55 years old. 2\. QTcF ≤450 msec and ≤470 for females. 3. Willing and able to give written informed consent and comply with the study visit schedule. 4\. Male subject and his female spouse/partner who is ...

Countries:United States
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Frequently asked questions about ALXN1007

What is ALXN1007 used for?

ALXN1007 is an investigational small molecule being studied in healthy subjects. It is not approved for any disease and is in Phase 1 clinical development. The completed trials evaluated its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers.

Who makes ALXN1007?

ALXN1007 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company conducted Phase 1 trials of the drug in healthy subjects in the United States.

What phase is ALXN1007 in?

ALXN1007 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials in healthy subjects have been completed.

What clinical trials is ALXN1007 in?

ALXN1007 has been studied in two completed Phase 1 trials: NCT01454986 and NCT01883544. Both trials evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects in the United States.

Is ALXN1007 the same as any other drug?

ALXN1007 is not known to have alternative names. It is a distinct investigational small molecule developed by AstraZeneca, and no other names for this drug have been reported.