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CompletedNCT00292942Updated Oct 25, 2018Results posted

Study of the Safety of Intravenous Artesunate

A Phase 1 interventional study of Intravenous Artesunate and Placebo in Malaria and Malaria, Cerebral, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by U.S. Army Medical Research and Development Command · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a multiple dose of the antimalarial drug artesunate.

Read the detailed description

This study was a Phase 1b, randomized, double-blind, placebo-controlled trial using multiple ascending doses of intravenous artensunate (AS) to determine it's safety, tolerability, and PK in healthy subjects. Subjects were screened within 21 days of dosing. At the screening visit, subject underwent baseline assessments: vital signs were recorded; a physical examination, urinalysis, urine drug screen, and urine pregnancy test were performed; a complete blood cell count (CBC) with differential and indices, reticulocyte count, coagulation markers, and blood chemistry assessments were performed and medical and medication history was collected. Eligible subjects were scheduled for a 6-hour pre-dose electrocardiogram (ECG) and vital sign assessment with measurements taken at approx. the same times as Day 1 (dosing day). On Day 0, subjects were admitted to the clinical pharmacology unit to begin the inpatient phase of the study. Subjects had a brief physical examination and all procedures for the inpatient stay were reviewed. On Day 1, pre-dose vital signs and ECG were performed. Subjects then received study drug or placebo by IV bolus infusion. Subjects were closely monitored by evaluating hemodynamic measurements, periodic ECGs, and assessment of spontaneously reported AEs. Blood was drawn for blood count and chemistry analysis 6h and 24h after each dose. PK blood samples were drawn pre-dose and approx. 5min, 20min, 40min, 1h, 2h, 4h, 6h, and 24h after each dose. On Days 2 and 3 subjects received their second and third doses, respectively, of study drug or placebo with the same monitoring and laboratory measurements as for the first dose. Subjects were discharged 24 hours after the 3rd dose of drug or placebo and were followed as outpatients on Days 7, 10, and 15.

02

Conditions studied

  • Malaria
  • Malaria, Cerebral

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Keywords

  • artesunate
  • artemisinin
  • falciparum
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 26 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

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 adult males and non-pregnant, non-lactating females
  • Have a normal ECG that may include benign PAC's and PVC's, 1st degree AV block, 2nd degree AV block, Wenckebach
  • Have a normal blood pressure (BP) and heart rate (HR). These will be measured after resting supine for about 3 minutes. Normal BP is defined as less than 140 mm Hg systolic and less than 90 mm Hg diastolic. Normal baseline HR is 50 to 90 bpm without symptoms.
  • Body mass index between 18 and 29 kg/m**2 or, if out of range, not clinically significant (within 15% of their ideal body weight).
  • Be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures
  • Have a physical examination that demonstrates no clinically significant contraindication for participating in the study. This would include documentation of any abnormal movements suggesting neurological pathology and ECG tracings to document an abnormalities in cardiac conduction
  • If female, have a negative serum pregnancy test at screening and urine pregnancy test on pre-admission and admission, or be postmenopausal, or have had a hysterectomy, or have been sterilized, AND, if still able to bear children, agree to practice effective contraception for the duration of the study and for a period of 12 weeks after stopping study drug.
  • Active duty participants must be on leave during the inpatient phase of the study.

Exclusion criteria

Exclusion Criteria:

  • Have received any investigational drug or vaccine in the period 0 to 16 weeks before entry to the study.
  • Have been on a liquid protein diet in the last year
  • Have any clinically important physical findings, laboratory abnormalities, or histories of Rx or OTC drug use that may, in the judgement of a study investigator, impact study interpretation or affect subject safety
  • Have used any prescription drugs within 14 days prior to admission or most non-prescription drugs including herbals or dietary supplements within 7 days prior to admission (at the investigator's discretion).
  • Existence of any surgical or medical condition that, in the judgement of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug
  • Presence of history of drug allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within the previous 2 months
  • Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
  • Serious adverse reaction or hypersensitivity to any drug, particularly artemisinin derivatives
  • CAGE (screening test for alcoholism) postitive (2 out of 4 criteria) or has a history of recent alcohol abuse
  • Use of illicit drugs
  • Family history (in 1st degree relatives) of sudden cardiac death or prolonged QT/QTc syndrome
  • History of seizure (excluding febrile seizures in childhood), episodes of unexplained syncope, or trouble with balance, undiagnosed hearing deficits, and other neurological disorder
  • History of severe psychiatric disorder or hospitalization for severe psychiatric disorder
  • Current job or personal habit of reversed sleep-wake cycle
  • History of cardiac disease to include cardiomyopathy, valvular disease, arrhythmia, ischemia, or enlarged heart
  • Presence of hepatitis B surface antigen (Hbs-Ag), hepatitis C antibody (antiHCV) or HIV type 1 at screening
  • A finding or history of hematuria (excluding menses-related hematuria) during subject screening
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    2 mg/kg Intravenous Artesunate

    2 mg/kg of Intravenous artesunate

    Drug: Intravenous Artesunate

  • Experimental
    4 mg/kg Intravenous Artesunate

    4 mg/kg of Intravenous artesunate

    Drug: Intravenous Artesunate

  • Experimental
    8 mg/kg Intravenous Artesunate

    8 mg/kg of Intravenous artesunate

    Drug: Intravenous Artesunate

  • Placebo comparator
    Placebo

    Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.

    Drug: Placebo

Interventions

  • DrugIntravenous Artesunate

    Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1)

    Also known as: IV AS

  • DrugPlacebo

    Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.

    Also known as: Mannitol

06

What researchers measure

Primary outcomes

  1. Number of Participants With AEs

    The general strategy of the safety analysis was to examine the clinical tolerability and laboratory safety parameter data and determine if there were any trends amongst the dose levels concerning all AEs and drug related AEs.

    Time frame: up to 21 days

  2. Number of Participants With AEs Occurring in Greater Frequency in the 2.0 mg/kg IV AS Group Then in the Placebo Group to Access Safety and Tolerability of AS

    Comparison of number of participants with AEs reported for the placebo control and those treated with the 2.0 mg/kg of IV AS to access safety and tolerability

    Time frame: up to 21 days

Secondary outcomes

  1. Cardiovascular Responses: Number of Participants With Changes in Blood Pressure and Heart Rate After Infusion

    Cardiovascular Responses: Number of participants with changes in blood pressure and heart rate after infusion to determine change from baseline

    Time frame: screening, on Day -1, on Days 1, 2, and 3, and at each follow-up visit

  2. Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)

    For artesunic acid, AUC0-last was determine for each dose; as well as the total area under the curve (AUClastTOTAL), calculated as the sum of AUClast for each of the doses (ng\*hr/mL)

    Time frame: Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion

  3. Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)

    For the predicted concentration at the time of dose administration (C0) was determine for each dose (ng/mL)

    Time frame: Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion

  4. Range of Pharmacokinetic Parameters for Dihydroartemisinin (DHA) After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)

    For DHA, AUC24, and AUClast were calculated for each dose, as well as the total area under the curve extrapolated to infinite time (AUC∞TOTAL), calculated as the sum of AUC24 for each dose +C24/λz.

    Time frame: Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion

  5. Cmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)

    Cmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (ng/mL)

    Time frame: Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion

  6. Tmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (hr)

    Tmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (hr)

    Time frame: Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion

07

Results

Posted Oct 25, 2018

Participant flow

A total of 47 subjects were screened over the 3 dose escalation cohorts of the study. Twenty-six subjects were enrolled and received IV AS at the USUHS, Clinical Pharmacology Unit (CPU), Bethesda, MD

Participant flow — Overall Study
MilestonePlacebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
Started6677
Completed6666
Not completed0011
Withdrew: Withdrawal by subject0010
Withdrew: Adverse event0001

Outcome measures

PrimaryNumber of Participants With AEs

The general strategy of the safety analysis was to examine the clinical tolerability and laboratory safety parameter data and determine if there were any trends amongst the dose levels concerning all AEs and drug related AEs.

Time frame:
up to 21 days
Reported as:
Count of participants · Participants
Number of Participants With AEs
ParticipantsPlacebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
All AEs — No AEs0020
All AEs — Subjects with 1 AE3302
All AEs — Subjects with 2 AEs3012
All AEs — Subjects with ≥3 AEs0343
Drug Related AEs — No AEs2021
Drug Related AEs — Subjects with 1 AE2312
Drug Related AEs — Subjects with 2 AEs2112
Drug Related AEs — Subjects with ≥3 AEs0232
PrimaryNumber of Participants With AEs Occurring in Greater Frequency in the 2.0 mg/kg IV AS Group Then in the Placebo Group to Access Safety and Tolerability of AS

Comparison of number of participants with AEs reported for the placebo control and those treated with the 2.0 mg/kg of IV AS to access safety and tolerability

Time frame:
up to 21 days
Reported as:
Count of participants · Participants
Number of Participants With AEs Occurring in Greater Frequency in the 2.0 mg/kg IV AS Group Then in the Placebo Group to Access Safety and Tolerability of AS
ParticipantsPlacebo2 mg/kg Intravenous Artesunate
Dysguesia14
Dizziness01
Headache13
Parethesia01
Parosmia01
Erythema01
Pruritus Generalized01
Tenderness01
Venipuncture Site Inflammation01
Eye Pain01
Back Pain01
Muscle Strain01
SecondaryCardiovascular Responses: Number of Participants With Changes in Blood Pressure and Heart Rate After Infusion

Cardiovascular Responses: Number of participants with changes in blood pressure and heart rate after infusion to determine change from baseline

Time frame:
screening, on Day -1, on Days 1, 2, and 3, and at each follow-up visit
Reported as:
Count of participants · Participants
Cardiovascular Responses: Number of Participants With Changes in Blood Pressure and Heart Rate After Infusion
ParticipantsPlacebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
Systolic BP change of at least 20mmHg — Increase1111
Systolic BP change of at least 20mmHg — Decrease0000
Systolic BP change of at least 20mmHg — No significant change5566
Heart Rate change of at least 15bpm — Increase4463
Heart Rate change of at least 15bpm — Decrease0000
Heart Rate change of at least 15bpm — No significant change2214
SecondaryRange of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)

For artesunic acid, AUC0-last was determine for each dose; as well as the total area under the curve (AUClastTOTAL), calculated as the sum of AUClast for each of the doses (ng\*hr/mL)

Time frame:
Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion
Reported as:
Mean · ng*hr/mL
Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)
ng*hr/mL2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
AUC24 1 (ng.hr/mL)1368 ± 9122325 ± 7215766 ± 2121
AUC24 2 (ng.hr/mL)978 ± 6481746 ± 2475272 ± 2089
AUC24 3 (ng.hr/mL)935 ± 3011880 ± 7954379 ± 2361
AUC last 1 (ng.hr/mL)1162 ± 6562421 ± 7554631 ± 2402
AUC last 2 (ng.hr/mL)932 ± 5241636 ± 3425728 ± 1980
AUC last 3 (ng.hr/mL)933 ± 2391627 ± 9574374 ± 2362
AUC last TOTAL (ng.hr/mL)3027 ± 11585683 ± 55014733 ± 5846
SecondaryRange of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)

For the predicted concentration at the time of dose administration (C0) was determine for each dose (ng/mL)

Time frame:
Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion
Reported as:
Mean · ng/mL
Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)
ng/mL2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
C0 114840 ± 1090229056 ± 1285053503 ± 33017
C0 211992 ± 831117265 ± 359066380 ± 32973
C0 310408 ± 185123417 ± 1020054674 ± 43261
SecondaryRange of Pharmacokinetic Parameters for Dihydroartemisinin (DHA) After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)

For DHA, AUC24, and AUClast were calculated for each dose, as well as the total area under the curve extrapolated to infinite time (AUC∞TOTAL), calculated as the sum of AUC24 for each dose +C24/λz.

Time frame:
Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion
Reported as:
Mean · ng*hr/mL
Range of Pharmacokinetic Parameters for Dihydroartemisinin (DHA) After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)
ng*hr/mL2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
AUC24 11982 ± 3774122 ± 8098992 ± 3355
AUC24 21865 ± 5123509 ± 9708122 ± 2750
AUC24 32204 ± 5243748 ± 6468571 ± 2817
AUC last 11954 ± 3674065 ± 7718842 ± 3265
AUC last 21847 ± 5163394 ± 9748011 ± 2780
AUC last 32171 ± 5193701 ± 6478405 ± 2715
AUC oo TOTAL6051 ± 107411379 ± 212825685 ± 8715
SecondaryCmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)

Cmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (ng/mL)

Time frame:
Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion
Reported as:
Mean · ng/mL
Cmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)
ng/mL2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
Cmax 11735 ± 5473015 ± 8826057 ± 2456
Cmax 21710 ± 7152923 ± 10505943 ± 2110
Cmax 32358 ± 6342933 ± 8105762 ± 3426
SecondaryTmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (hr)

Tmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (hr)

Time frame:
Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion
Reported as:
Mean · hr
Tmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (hr)
hr2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
Tmax 1 (hr)0.244 ± 0.1320.208 ± 0.1370.208 ± 0.137
Tmax 2 (hr)0.167 ± 0.1290.208 ± 0.1370.181 ± 0.238
Tmax 3 (hr)0.122 ± 0.1040.292 ± 0.1020.250 ± 0.129

Adverse events

Collected over up to 21 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/6 (0%)0/6 (0%)6/6 (100%)
2 mg/kg Intravenous Artesunate0/6 (0%)0/6 (0%)6/6 (100%)
4 mg/kg Intravenous Artesunate0/7 (0%)0/7 (0%)6/7 (85.7%)
8 mg/kg Intravenous Artesunate0/7 (0%)0/7 (0%)7/7 (100%)
Most frequent other events
Showing 10 of 36
Most frequent other events
EventPlacebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous Artesunate
DysgeusiaNervous system disorders1/64/66/76/7
AnemiaBlood and lymphatic system disorders3/61/64/70/7
HeadacheNervous system disorders1/63/62/71/7
DizzinessNervous system disorders0/61/61/71/7
ParaesthesiaNervous system disorders0/61/61/70/7
ParosmiaNervous system disorders0/61/60/70/7
ErythemaSkin and subcutaneous tissue disorders0/61/60/70/7
Pruritus generalisedSkin and subcutaneous tissue disorders0/61/60/70/7
BacteriuriaInfections and infestations1/60/60/70/7
DehydrationMetabolism and nutrition disorders1/60/60/70/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
Mean36.0 ± 10.4143.2 ± 12.0235.3 ± 9.9635.0 ± 11.8637.2 ± 10.95
Sex: Female, Male
Sex: Female, Male(Participants)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
Female10102
Male566724
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
White243312
Black or African American40239
American Indian or Alaska Native00011
Hispanic or Latino00000
Asian00101
Native Hawaiian or Pacific Islander00000
Other00000
Subjects with >1 race02103
Region of Enrollment
Region of Enrollment(Participants)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
United States667726
Height (cm)
Height (cm)(cm)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
Mean173.68 ± 7.598172.97 ± 3.634173.14 ± 12.472175.34 ± 2.519173.82 ± 7.348
Weight (kg)
Weight (kg)(kg)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
Mean80.33 ± 8.39076.53 ± 11.11481.03 ± 12.68177.80 ± 5.91278.96 ± 9.445
Body Mass Index (kg/m^2)
Body Mass Index (kg/m^2)(kg/m^2)Placebo2 mg/kg Intravenous Artesunate4 mg/kg Intravenous Artesunate8 mg/kg Intravenous ArtesunateTotal
Mean26.68 ± 2.91725.50 ± 2.82826.89 ± 2.27025.30 ± 1.62826.09 ± 2.386
08

Study locations

1 site
  • Uniformed Services University of the HEalth Sciences
    Bethesda, Maryland 20814-4799, United States
09

References and documents

Individual participant data

Plan to share: Yes — WRAIR

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00292942
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborators
Walter Reed Army Institute of Research (WRAIR)
Responsible party
Sponsor
First posted
Feb 16, 2006
Start date
Jun 12, 2006
Primary completion
Jan 17, 2007
Completion
Jan 2008
Results posted
Oct 25, 2018
Last update
Oct 25, 2018

Study contacts

Peter J Weina, MD, PhD
study director · Walter Reed Army Institute of Research (WRAIR)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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