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NCT ID: NCT05665751 Not yet recruiting - Insulin Resistance Clinical Trials

A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance

Start date: February 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, multicenter, double-blind, randomized study designed to evaluate the safety, tolerability, effectiveness, and pharmacokinetics of TLC-3595 activity in participants with insulin resistance.

NCT ID: NCT05651347 Recruiting - Clinical trials for Fetal Growth Retardation

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

PROTECTMe
Start date: May 29, 2019
Phase: Phase 3
Study type: Interventional

Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia. This triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.

NCT ID: NCT05645861 Recruiting - Stroke Clinical Trials

MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE

MASTERSTROKE
Start date: November 28, 2019
Phase: N/A
Study type: Interventional

Stroke is the third most common cause of death in New Zealand and is one of the leading causes of long-term disability at all ages. A life-saving clot retrieval procedure can save lives and prevent disability of patients with ischaemic stroke who get to hospital in time. In New Zealand, 90% of clot retrieval procedures are performed under general anaesthesia. Many anaesthetic drugs can affect blood pressure (BP) and blood flow within the brain. Increasing BP during the procedure could provide additional benefits in this devastating disease. A large trial is needed to investigate BP management during clot retrieval.

NCT ID: NCT05638854 Recruiting - Healthy Volunteers Clinical Trials

A Safety, Tolerability, and Pharmacokinetics Study of ZB002 in Healthy Participants

Start date: December 8, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single-ascending doses of ZB002.

NCT ID: NCT05633745 Not yet recruiting - Healthy Clinical Trials

A Study to Assess NEU-723 in Healthy Participants

Start date: January 16, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), of orally administered NEU-723 in healthy subjects.

NCT ID: NCT05632211 Recruiting - Clinical trials for Healthy Adult Subjects

A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

Start date: December 16, 2022
Phase: Phase 1
Study type: Interventional

Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.

NCT ID: NCT05626803 Recruiting - Clinical trials for Norovirus Infections

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers

Start date: December 15, 2022
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

NCT ID: NCT05624177 Recruiting - Clinical trials for Microbial Colonization

Colonisation Efficacy of a Probiotic Chewing Gum.

Start date: December 2022
Phase: N/A
Study type: Interventional

To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

NCT ID: NCT05616013 Recruiting - Obesity Clinical Trials

Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

Start date: November 16, 2022
Phase: Phase 2
Study type: Interventional

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

NCT ID: NCT05612581 Recruiting - Clinical trials for Hepatitis B, Chronic

A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

Start date: November 9, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic HBV infection.