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NCT ID: NCT05158023 Completed - Atopic Dermatitis Clinical Trials

Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

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

Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo).

NCT ID: NCT05154240 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 1, Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy Subjects

Start date: February 21, 2022
Phase: Phase 1
Study type: Interventional

The sponsor is planning to conduct a Phase 1, randomized, double-blind, placebo-controlled, oral single and multiple ascending-doses, parallel group study to evaluate the safety, tolerability and PK of INS018_055 in healthy subjects. The study will be conducted in 1 clinical site in the New Zealand, consisting of 2 parts: Part A (single ascending dose [SAD]) and Part B (multiple ascending dose [MAD]).

NCT ID: NCT05127564 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

Start date: December 3, 2021
Phase: Phase 1
Study type: Interventional

The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.

NCT ID: NCT05126784 Completed - Clinical trials for Healthy Male Subjects

AVT03 With Prolia in Healthy Male Subjects

Start date: June 29, 2022
Phase: Phase 1
Study type: Interventional

This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD, safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a single SC dose.

NCT ID: NCT05121246 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.

Start date: June 15, 2022
Phase: Phase 1
Study type: Interventional

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU Synagis® in healthy subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

NCT ID: NCT05114265 Completed - Acute Pain Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults

Start date: February 15, 2022
Phase: Phase 1
Study type: Interventional

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single doses of a new drug called KUR-101. Up to 58 healthy men or women aged between 18-55 will be enrolled in this study in two parts. Part 1 will involve a single ascending (increasing) dose (SAD) where 40 participants (5 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. Part 2: will involve a crossover design where 18 participants will be randomised to receive a single oral dose of each of three interventions (study drug, placebo or a marketed form of oxycodone). Each dose is separated by 7 days and the participants are randomised so they do not know the order of the interventions. For Part 1 the total participation will last 9 days, of which 4 days (3 nights) will be spent in the clinic. One group of subjects in Part 1 will return to the clinic to receive a second dose of drug given with a high fat breakfast. In this group, the total participation will last 16 days, of which 8 days (7 nights) will be spent in the clinic. For Part 2 the total participation will last 23 days, of which 9 days (8 nights) will be spent in the clinic.

NCT ID: NCT05104463 Completed - Dementia Clinical Trials

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease

Start date: April 12, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, randomized, placebo-controlled, double-blind, crossover study to evaluate the effects CST-2032 administered with CST-107 on cognition in subjects with Mild Cognitive Impairment (MCI) or mild dementia.

NCT ID: NCT05090046 Completed - Clinical trials for Trauma, Psychological

Understanding Neurocognitive Impairment After Trauma Exposure

UNITE
Start date: February 10, 2022
Phase:
Study type: Observational

Individuals living in Canterbury (New Zealand) have experienced significant stress related to the Canterbury earthquake sequence. Previous research conducted at the Department of Psychological Medicine (Christchurch, New Zealand) has shown significant cognitive difficulties in a group of Cantabrians exposed to high levels of earthquake trauma. A high proportion (30%) perceive themselves to have significant cognitive difficulties, even seven years post-earthquake. People who perceive that they have cognitive difficulties find this distressing and tend to function less well in work and parenting. Understanding pathways underlying cognitive difficulties in the population is vital for developing appropriate treatments and strategies to help with this. This will be the first study to investigate rates of, and factors contributing to, perceived cognitive difficulties in a large population exposed to multiple stressors and is important for the population of Canterbury, and populations affected by natural and man-made disasters worldwide. Four hundred and sixty people who were exposed to the Canterbury earthquake sequence will be recruited from the Christchurch Health and Development Study (CHDS). Psychological, cognitive, functional and biological factors will be compared between those with the greatest levels of perceived cognitive difficulty and those with the lowest levels of difficulty. This will determine what factors relate most strongly to perceived cognitive difficulties, which will in turn be used to develop treatments for this population.

NCT ID: NCT05089409 Completed - Onychomycosis Clinical Trials

A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis

Start date: March 4, 2022
Phase: Phase 1
Study type: Interventional

The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis.

NCT ID: NCT05082051 Completed - Clinical trials for Exocrine Pancreatic Insufficiency

Oral CDX-7108 in Healthy Adults and EPI Subjects

Start date: October 11, 2021
Phase: Phase 1
Study type: Interventional

Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency. No clinical studies have yet been performed with CDX-7108 and its effects in humans are unknown. This is the first-in-human (FIH) study of CDX-7108, which aims to assess the safety, tolerability, pharmacokinetics (PK) of escalating single and multiple oral doses of CDX-7108 in healthy adult subjects and to evaluate the pharmacodynamics of a single dose of oral CDX-7108 in a proof-of-concept (POC) study in subjects with exocrine pancreatic insufficiency (EPI).