CClinicalTrials.gg
Sign In
CompletedNCT00979875Updated Jul 14, 2014Results posted

A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

A Phase 1 interventional study of Recombinant human hyaluronidase PH20 (rHuPH20) and Insulin lispro in Healthy, sponsored by Halozyme Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-14.

Sponsored by Halozyme Therapeutics · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

02

Conditions studied

  • Healthy

Keywords

  • insulin
  • recombinant human hyaluronidase
  • Healthy volunteers
03

In context

Lead sponsor

Halozyme Therapeutics is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy participants between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities).
  • Body mass index (BMI) between 18-27 kilograms per meter squared (kg/m\^2), inclusive.
  • Total body weight >65 kilograms (kg) (143 pounds [lb]) for men and >46 kg (101 lb) for women.
  • Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.
  • Vital signs (blood pressure [BP], pulse rate, body temperature) within normal range or, if out of range, assessed by the Principal Investigator as not clinically significant.
  • Fasting blood glucose level \<100 milligrams per deciliter (mg/dL) at screening.
  • A negative serum pregnancy test (if female of childbearing potential).
  • Female participants of childbearing potential must agree to practice effective birth control or abstinence currently and agree to continue to do so for the duration of their time on study.
  • Signed, written institutional review board (IRB)-approved informed consent.

Exclusion criteria

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the Principal Investigator.
  • As judged by the investigator, clinically significant findings in routine laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
  • Known history of diabetes mellitus (type 1 or type 2) or gestational diabetes.
  • Known allergy to hyaluronidase or any other ingredient in the study drug.
  • Positive human immunodeficiency virus (HIV) 1, hepatitis B, or hepatitis C antibody test.
  • History or evidence of alcohol or drug abuse.
  • History or evidence of use of any tobacco- or nicotine-containing product within 6 months prior to screening and a screening qualitative urine nicotine test.
  • Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization.
  • Blood donation or high volume phlebotomy, for example, >100 milliliters (mL), within 56 days before dosing.
  • Participation in a study of any investigational drug or device 30 days before enrollment in this study.
  • The participant is unfit for the study in the opinion of the investigator.
  • Women who are pregnant or breast-feeding.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Lispro+PH20, Lispro, Glulis+PH20, Glulis, Aspart+PH20, Aspart

    All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout. Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart. Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart. Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart.

    Drug: Recombinant human hyaluronidase PH20 (rHuPH20) · Drug: Insulin lispro · Drug: Insulin glulisine · Drug: Insulin aspart

Interventions

  • DrugRecombinant human hyaluronidase PH20 (rHuPH20)

    Also known as: HYLENEX, PH20

  • DrugInsulin lispro

    Also known as: Humalog, Lispro

  • DrugInsulin glulisine

    Also known as: Apidra, Glulisine

  • DrugInsulin aspart

    Also known as: NovoLog, Aspart

06

What researchers measure

Primary outcomes

  1. Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)

    Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.

    Time frame: Predose up to 60 minutes postdose

Secondary outcomes

  1. Time to Maximum Serum Insulin Concentration (Tmax)

    Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

    Time frame: Predose up to 480 minutes postdose

  2. Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])

    Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

    Time frame: Predose up to 480 minutes postdose

  3. Time to Maximum Glucose Infusion Rate (tGIR[Max])

    Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

    Time frame: Predose up to 480 minutes postdose

  4. Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)

    Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.

    Time frame: Predose up to 120 minutes postdose

  5. Time to Percentage of Total Insulin Exposure

    Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

    Time frame: Predose up to 480 minutes postdose

07

Results

Posted Jul 14, 2014

Participant flow

Intervention 1
Participant flow — Intervention 1
MilestoneLispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, AspartLispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, LisproAspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis
Started223232
Received at least 1 dose of study drug223232
Completed223232
Not completed000000
Washout 1 (3 to 14 Days)
Participant flow — Washout 1 (3 to 14 Days)
MilestoneLispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, AspartLispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, LisproAspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis
Started223232
Completed223232
Not completed000000
Intervention 2
Participant flow — Intervention 2
MilestoneLispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, AspartLispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, LisproAspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis
Started223232
Completed223232
Not completed000000
Washout 2 (3 to 14 Days)
Participant flow — Washout 2 (3 to 14 Days)
MilestoneLispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, AspartLispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, LisproAspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis
Started223232
Completed223232
Not completed000000
Intervention 3
Participant flow — Intervention 3
MilestoneLispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, AspartLispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, LisproAspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis
Started223232
Completed223232
Not completed000000

Outcome measures

PrimaryArea Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)

Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.

Time frame:
Predose up to 60 minutes postdose
Reported as:
Mean · minutes*nanomolars (min*nM)
Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)
minutes*nanomolars (min*nM)Glulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)11667.14 ± 4085.0023807.14 ± 6657.7310687.14 ± 5532.4927850.00 ± 9684.948065.00 ± 3138.3720778.57 ± 6383.05
Statistical analysis
  • Glulisine Alone vs Glulisine + rHuPH20 · Mixed Models Analysis · p = <0.0001 (Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.) · Geometric least squares mean ratio: 2.08 · 90% CI 1.70 to 2.55Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.
  • Lispro Alone vs Lispro + rHuPH20 · Mixed Models Analysis · p = <0.0001 (Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.) · Geometric least squares means ratio: 5.26 · 90% CI 3.88 to 7.12Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.
  • Aspart Alone vs Aspart + rHuPH20 · Mixed Models Analysis · p = <0.0001 (Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.) · Geometric least squares means ratio: 4.14 · 90% CI 3.05 to 5.60Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.
SecondaryTime to Maximum Serum Insulin Concentration (Tmax)

Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

Time frame:
Predose up to 480 minutes postdose
Reported as:
Mean · minutes
Time to Maximum Serum Insulin Concentration (Tmax)
minutesGlulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
Time to Maximum Serum Insulin Concentration (Tmax)80.36 ± 25.3841.43 ± 12.4767.50 ± 32.0941.07 ± 17.5685.71 ± 35.9943.57 ± 12.92
Statistical analysis
  • Glulisine Alone vs Glulisine + rHuPH20 · ANOVA · p = <0.0001 (Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.) · Least square mean difference: -38.93 · 90% CI -53.31 to -24.55Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.
  • Lispro Alone vs Lispro + rHuPH20 · ANOVA · p = 0.0032 (Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.) · Least square mean difference: -26.43 · 90% CI -40.81 to -12.05Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.
  • Aspart Alone vs Aspart + rHuPH20 · ANOVA · p = <0.0001 (Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.) · Least square mean difference: -42.14 · 90% CI -56.53 to -27.76Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.
SecondaryTime to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

Time frame:
Predose up to 480 minutes postdose
Reported as:
Mean · minutes
Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
minutesGlulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
early t(50%max)21.06 ± 9.6010.16 ± 4.9030.69 ± 12.5818.96 ± 5.2731.93 ± 8.1517.98 ± 5.22
late t(50%max)195.43 ± 48.63118.92 ± 33.57176.79 ± 30.0089.59 ± 21.38193.50 ± 45.94102.82 ± 24.74
SecondaryTime to Maximum Glucose Infusion Rate (tGIR[Max])

Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

Time frame:
Predose up to 480 minutes postdose
Reported as:
Mean · minutes
Time to Maximum Glucose Infusion Rate (tGIR[Max])
minutesGlulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
Time to Maximum Glucose Infusion Rate (tGIR[Max])141.93 ± 71.18113.36 ± 69.85160.14 ± 71.36103.57 ± 58.83158.79 ± 52.3496.93 ± 56.65
SecondaryPercentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)

Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.

Time frame:
Predose up to 120 minutes postdose
Reported as:
Mean · percentage of total AUC
Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
percentage of total AUCGlulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
AUC0-152.02 ± 1.105.29 ± 2.060.68 ± 0.652.38 ± 1.240.56 ± 0.302.92 ± 2.28
AUC0-307.09 ± 3.4015.82 ± 5.563.88 ± 2.7113.81 ± 5.373.54 ± 1.9013.66 ± 7.05
AUC0-6020.68 ± 8.0739.45 ± 10.6418.72 ± 7.7442.88 ± 8.8916.85 ± 6.5441.51 ± 12.06
AUC0-12050.35 ± 12.6971.70 ± 11.0750.14 ± 12.1077.00 ± 7.5447.97 ± 12.3277.37 ± 8.80
SecondaryTime to Percentage of Total Insulin Exposure

Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.

Time frame:
Predose up to 480 minutes postdose
Reported as:
Mean · minutes
Time to Percentage of Total Insulin Exposure
minutesGlulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
Time to 10% of total insulin exposure39.59 ± 9.9523.39 ± 6.3846.56 ± 11.8926.35 ± 5.6048.42 ± 9.9626.99 ± 6.57
Time to 50% of total insulin exposure123.65 ± 27.4878.64 ± 18.82123.39 ± 27.8770.97 ± 12.61130.86 ± 30.0472.53 ± 14.86

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Glulisine Alone—0/14 (0%)1/14 (7.1%)
Glulisine + rHuPH20—0/14 (0%)2/14 (14.3%)
Lispro Alone—0/14 (0%)2/14 (14.3%)
Lispro + rHuPH20—0/14 (0%)3/14 (21.4%)
Aspart Alone—0/14 (0%)2/14 (14.3%)
Aspart + rHuPH20—0/14 (0%)2/14 (14.3%)
Most frequent other events
Most frequent other events
EventGlulisine AloneGlulisine + rHuPH20Lispro AloneLispro + rHuPH20Aspart AloneAspart + rHuPH20
Infusion site anaesthesiaGeneral disorders0/140/140/140/141/140/14
Infusion site painGeneral disorders0/141/140/140/140/141/14
Infusion site abscessInfections and infestations0/140/140/141/140/140/14
RhinitisInfections and infestations0/140/141/140/140/140/14
ContusionInjury, poisoning and procedural complications0/140/140/141/140/140/14
HeadacheNervous system disorders1/141/141/141/141/140/14
CoughRespiratory, thoracic and mediastinal disorders0/140/140/140/140/141/14
Nasal congestionRespiratory, thoracic and mediastinal disorders0/140/141/140/140/140/14
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/140/140/140/140/141/14
EcchymosisSkin and subcutaneous tissue disorders0/140/141/140/140/140/14

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)Overall Study
Mean33.7 ± 8.96
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female6
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall Study
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander1
Black or African American2
White10
More than one race0
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Overall Study
Hispanic or Latino4
Not Hispanic or Latino10
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Overall Study
United States14
08

Study locations

1 site
  • Profil Institute for Clinical Research, Inc.
    Chula Vista, California 91911, United States
09

References and documents

Publications

  • Morrow L, Muchmore DB, Hompesch M, Ludington EA, Vaughn DE. Comparative pharmacokinetics and insulin action for three rapid-acting insulin analogs injected subcutaneously with and without hyaluronidase. Diabetes Care. 2013 Feb;36(2):273-5. doi: 10.2337/dc12-0808. Epub 2012 Oct 5. PubMed 23043164 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00979875
Lead sponsor
Halozyme Therapeutics
Responsible party
Sponsor
First posted
Sep 18, 2009
Start date
Sep 2009
Primary completion
Feb 2010
Completion
May 2010
Results posted
Jul 14, 2014
Last update
Jul 14, 2014

Study contacts

Marcus Hompesch, M.D.
principal investigator · Profil Institute for Clinical Research, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Halozyme Therapeutics

Start the discussion