Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882 in Healthy Adult Male Volunteers

Phase 1

Completed

• Conditions: Chronic gout; Hyperuricemia; Musculoskeletal - Other muscular and skeletal disorders; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12619000021178
• Lead Sponsor: Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-09
• Study Completion: 2019-07-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

1. Healthy male adult subjects greater than or equal to 18 and lesser than or equal to 55 years of age.
2. Male subjects must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, must agree to use contraception as described in the protocol.
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. 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.
5. Screening serum uric acid level greater than or equal to 4.5 mg/dL (268 µmol/L).

Exclusion Criteria

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. Subjects who have undergone major surgery within 3 months of Day 1.
7. Use of tobacco products within 30 days prior to dosing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified