ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31648 results sorted by trial registration date.
  • Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults

    BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara® (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat people with Crohn's disease, Ulcerative Colitis, plaque psoriasis and psoriatic arthritis. Stelara® is an immune suppressant that reduces the effects of inflammatory proteins within the body. This is the first time BFI-751 will be given to humans. The primary purpose of this study is to compare the pharmacokinetics (the study of what the body does to the drug, referring to the movement of any drug going into, through, and out of the body) by checking to see if the blood levels of 751-BFI are comparable with US-Stelara® and EU-Stelara® following a single injection under the skin. The secondary purposes of this study are: * to assess the safety of BFI-751, * study how well the healthy volunteers tolerate it and * to also assess the immune response to it in healthy volunteers.

  • Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis

    Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.

  • First-in Human (FIH) Trial of ETH-155008 in Subjects With B-NHL, CLL/SLL and AML

    This Trial is a FIH, open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with R/R B-cell NHL, CLL/SLL and AML who previously received standard treatment or are ineligible for standard treatment options.

  • A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,

    The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea).

  • Single Position Spine Surgery Registry

    The purpose of this study is to systematically, prospectively compare surgical fusion techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and revision rates following surgery.

  • Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

    The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.

  • A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers

    This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM), intranasal (IN) or inhaled (IH) route in healthy volunteers.

  • REZUM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

    The study objective is to compare water vapor thermotherapy with the REZUM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

  • A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus

    This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.

  • Alleviate-HF-2 Study

    Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF = 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% \< EF \< 50%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data

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