Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-19

Study Completion Date

2016-12-05

Brief Summary

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This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).

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Detailed Description

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment 1- 4

Treatment A: 9 Subjects will receive dose level I of SHP623 intravenously (IV). B: 9 Subjects will receive dose level I of SHP623 subcutaneously(SC).

Group Type EXPERIMENTAL

Recombinant human C1 esterase inhibitor

Intervention Type DRUG

Subjects will receive escalating doses I-IV as both IV and SC injections

SHP623

Intervention Type DRUG

SHP623

Placebo

3 Subjects will receive placebo for each cohort

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive matching placebo

Placebo

Intervention Type DRUG

Placebo

Interventions

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Recombinant human C1 esterase inhibitor

Subjects will receive escalating doses I-IV as both IV and SC injections

Intervention Type DRUG

Placebo

Subjects will receive matching placebo

Intervention Type DRUG

SHP623

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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SHP623

Eligibility Criteria

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Inclusion Criteria

1. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease
2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-child-bearing potential.
3. Body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight \>50 kg (110 lbs.). This inclusion criterion will be assessed only at the first screening visit.
4. Hemoglobin ≥12.0g/ld.

Exclusion Criteria

1. Have a history of allergic reaction to C1 INH products (e.g. C1 Inhibitor \[Human\], Berinert \[C1 Estrace Inhibitor (Human)\] and C1 estrace \[recombinant\]
2. Known history of alcohol or other substance abuse within the last year.
3. Donation of blood or blood products within 60 days prior to receiving investigational product.
4. Current use of any medication except hormonal replacement therapy, hormonal contraceptives and occasional use of any over-the-counter non-steroidal anti-inflammatory drug (NSAID) or acetaminophen.
5. Have a history of hypercoagulability or other predisposition to thrombotic events.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes