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NCT ID: NCT06141889 Completed - Clinical trials for Healthy Volunteer Study

Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers

Start date: November 17, 2023
Phase: Phase 1
Study type: Interventional

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers.

NCT ID: NCT06139328 Recruiting - Clinical trials for Myocardial Infarction

IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack

IRI-EXPLORE
Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 4 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06138743 Recruiting - Clinical trials for Myotonic Dystrophy 1

Study of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy

Start date: March 4, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1/2a double-blinded, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of ARO-DM1 compared to placebo in male and female subjects with Type 1 Myotonic Dystrophy (DM1). Participants who have provided written informed consent and met all protocol eligibility requirements will be randomized to receive single (Part 1) or multiple (Part 2) doses of ARO-DM1 or placebo.

NCT ID: NCT06137482 Active, not recruiting - Healthy Volunteers Clinical Trials

A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

Start date: December 6, 2023
Phase: Phase 1
Study type: Interventional

This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults. The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is present in the blood of study participants at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

NCT ID: NCT06137404 Enrolling by invitation - Trigger Finger Clinical Trials

A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate the effectiveness of two splint designs in conservative management of trigger finger.

NCT ID: NCT06137209 Active, not recruiting - Clinical trials for Microbial Colonization

Colonization of Skin by M. Luteus Q24 Probiotic

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the face from a serum format in healthy adults.

NCT ID: NCT06137001 Completed - COVID-19 Clinical Trials

Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

Start date: April 20, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). - Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group - The duration of the study for each participant will be approximately 2 months - There are 3 scheduled study visits each about 1 month apart - The study will be conducted in New Zealand and Australia.

NCT ID: NCT06136819 Recruiting - Clinical trials for Lower Urinary Tract Symptoms

RT-310 Dose Escalation BPH Study

Start date: April 19, 2024
Phase: Phase 1
Study type: Interventional

RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

NCT ID: NCT06136650 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

NCT ID: NCT06131983 Recruiting - Clinical trials for Facio-Scapulo-Humeral Dystrophy

Study of ARO-DUX4 in Adult Patients With Facioscapulohumeral Muscular Dystrophy Type 1

Start date: February 26, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-DUX4 in participants with facioscapulohumeral muscular dystrophy Type 1 (FSHD1). In Part 1 of the study, participants will receive a single dose of ARO-DUX4 or placebo. In Part 2 of the study, participants will receive 2 or 4 doses of ARO-DUX4 or placebo. Participants who complete Part 1 will have the option to re-screen and re-randomize into Part 2. All participants will undergo pre- and post-dose MRI-guided muscle biopsies (a total of 2 biopsies). Participants who complete Part 1 and enroll in Part 2 will be required to undergo an additional screening biopsy. Participants completing Part 1 or Part 2 may have the option to continue to receive drug in an open-label extension study or may be eligible to participate in later-stage clinical studies.