Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers
- Conditions
- Chronic goutHyperuricemiaMusculoskeletal - Other muscular and skeletal disordersMetabolic and Endocrine - Other metabolic disordersInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12619000908134
- Lead Sponsor
- Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
1.Healthy male adult subjects greater than or equal to 18 and lesser than or equal to 55 years of age.
2.Males must be surgically sterile, abstinent* or, if engaged in sexual relations with a female of child-bearing potential, the subject must agree to use 2 forms of a highly effective contraceptive methods from the time of signing the informed consent form until at least 90 days after receiving IP (AR882 or placebo).
* Abstinence is only acceptable as true abstinence as part of a preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar ovulation, symptom-thermal, post-ovulation methods), declaration of abstinences for the duration of the trial and withdrawal are not acceptable methods of contraception.
3.Males must agree to refrain from sperm donation from the time of signing the informed consent form until at least 90 days after receiving IP (AR882 or placebo).
4.Able to understand the study procedures, the risks involved and willing to provide written Informed Consent before the first trial related activity.
5.Body weight no less than 50 kg and body mass index (BMI) within the range of
greater than or equal to 18 and lesser than or equal to 33 kg/m2.
6.All laboratory parameters (chemistry, hematology, and urinalysis) should be within normal limits or considered not clinically significant by the Investigator, in consultation with the Sponsor.
7.Screening serum uric acid level greater than or equal to 4.5 mg/dL (268 micromol/L) and less than 9 mg/dL (535 micromol/L) and estimated Glomerular Filtration Rate (eGFR) greater than or equal to 90 mL/min/1.73 m².
8.Subjects must be free of any clinically significant disease that requires a physician’s care and/or would interfere with study evaluations or procedures.
9.Normal or clinically acceptable physical examination.
10.No clinically relevant abnormalities in twelve-lead electrocardiogram as per Investigator judgment.
11.No clinically relevant abnormalities in blood pressure (BP), heart rate (HR), body temperature and respiratory rate as per the Investigator’s judgment, see normal values for information:
a.90 mm Hg lesser than or equal to systolic BP lesser than or equal to 140 mmHg in supine position.
b.40 mm Hg lesser than or equal to diastolic BP lesser than or equal to 90 mm Hg in supine position.
c.40 bpm lesser than or equal to heart rate lesser than or equal to 100 bpm in supine position.
d.35.5 °C lesser than or equal to body temperature lesser than or equal to 37.5 °C.
e.10 bpm lesser than or equal to respiratory rate lesser than or equal to 22 bpm.
1. Inadequate venous access or unsuitable veins for repeated venipuncture.
2. Any concomitant chronic or acute illness or an acute febrile illness within 1 week
of dose administration.
3. Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies (HCV),
and/or Hepatitis B surface antigen (HBsAg).
4. History or clinical manifestations of significant metabolic, hematological,
pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological,
or psychiatric disorders.
5. Malignancy within 5 years, except for basal or squamous cell carcinoma of the
skin that has been successfully treated. Healthy volunteers with a history of other
malignancies that have been treated with curative intent and which have no
recurrence within 5 years may also be eligible if approved by the Sponsor
Medical Monitor (or designee).
6. History of cardiac abnormalities including abnormal and clinically relevant ECG
changes such as bradycardia (sinus rate < 40 bpm), complete LBBB, RBBB,
incomplete LBBB, second or third degree heart block, intraventricular conduction
delay with QRS duration > 120 msec, symptomatic or asymptomatic arrhythmias
with the exception of sinus arrhythmia, evidence of ventricular pre-excitation,
frequent palpitations or syncopal episodes, heart failure, hypokalemia, family
history of Long QT Syndrome, family history of sudden death in otherwise
healthy individual between the ages of 1 and 30 years.
7. Conditions predisposing to QT prolongation including pathological Q-wave
(defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
8. Any use of concomitant medications that prolong the QT/QTc interval within
14 days prior to Day 1.
9. Subjects with a QTcF interval (QT interval corrected for heart rate according to
Fridericia) > 450 milliseconds (ms) at Screening or on Day –1 or at pre-dose on
Day 1.
10. Subjects who have undergone major surgery within 3 months of Day 1.
11. Subjects who previously received AR882 or an investigational product, biological
agent, or device within 3 months or 5 half-lives of the investigational agent,
whichever is longer.
12. Subjects who donated blood within 12 weeks prior to Day 1 or who have given a
plasma donation within 4 weeks prior to the screening visit.
13. Any drug treatment, including prescribed or OTC medicines or herbal
preparations, taken in the 14 days (2 months for enzyme-inducing drugs or
products e.g., glucocorticoids, phenobarbital, isoniazid, St. John’s Wort)
preceding the dosing of IP.
14. Use of tobacco products within 30 days prior to dosing.
15. Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee,
tea, cola per day).
16. Subjects who refuse to abstain from alcohol, or caffeine containing foods or
beverages, or grapefruit containing foods or beverages, or Seville orange
containing foods or beverages, or fruit juice, or sweetened soft drinks from 48
hours prior to dosing and for the entire duration of the study.
17. History and/or presence of drug addiction or excessive use of alcohol within 6
months prior to Screening defined as > 14 drinks/week (1 drink = 5 ounces
(150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard
liquor).
18. Subjects who have a positive alcohol test (breath or urine test) at Screening or at
Day -2 (Admission).
19. Subjects who have a positive test for drugs of abuse (cocaine,
tetrahydrocannabinol, methamphetamine, amphetamine, benzodiazepines,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method