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Healthy Volunteers clinical trials

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NCT ID: NCT05429073 Completed - Healthy Volunteers Clinical Trials

A Study of RGLS8429 in Healthy Volunteers

Start date: June 10, 2022
Phase: Phase 1
Study type: Interventional

Primary Objective • To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives - To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429 - To characterize the pharmacokinetic (PK) properties of RGLS8429

NCT ID: NCT05426174 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

Start date: June 9, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

NCT ID: NCT05419401 Completed - Healthy Volunteer Clinical Trials

A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)

Start date: April 11, 2022
Phase: Phase 1
Study type: Interventional

The Sponsor is developing the test medicine, Capivasertib, for the potential treatment of primary breast and prostate cancer. This two-part healthy volunteer study will try to identify the absolute bioavailability (amount of the test medicine that enters the blood stream), mass balance recovery (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of the test medicine.

NCT ID: NCT05418803 Completed - Healthy Volunteer Clinical Trials

BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects

Start date: January 28, 2020
Phase: Phase 1
Study type: Interventional

The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.

NCT ID: NCT05413863 Completed - Healthy Volunteers Clinical Trials

Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects

RHINE-4
Start date: May 30, 2022
Phase: Phase 1
Study type: Interventional

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

NCT ID: NCT05411588 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People

Start date: June 9, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants. This study is seeking participants who: - Are healthy as determined by medical evaluation. - Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. - Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds) Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.

NCT ID: NCT05411016 Recruiting - Healthy Volunteers Clinical Trials

A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

Start date: July 19, 2022
Phase: Phase 1
Study type: Interventional

Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).

NCT ID: NCT05409300 Active, not recruiting - COVID-19 Clinical Trials

Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea

CovicompareG
Start date: April 25, 2022
Phase: Phase 2
Study type: Interventional

Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.

NCT ID: NCT05408091 Recruiting - Healthy Volunteers Clinical Trials

Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers

Start date: September 14, 2023
Phase: Phase 1
Study type: Interventional

This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as design and conduct of a clinical study in transplant patients.

NCT ID: NCT05406219 Withdrawn - Healthy Volunteers Clinical Trials

A Study to Learn How the Study Treatment BAY2395840 Moves Into, Through and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Moderate Reduced Kidney Function and in Healthy Male and Female Participants With Normal Kidney Function

Start date: May 15, 2023
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have inflammatory conditions. Inflammatory conditions may result from an increased activation of the body's natural defenses (the immune system) and are characterized by swelling, redness, heat, and pain. The study treatment BAY2395840 is under development for use in inflammatory conditions. It works by blocking a protein, the B1 receptor, whose activation is involved in inflammatory responses. The main purpose of this study is to learn how a single dose of BAY2395840 moves into, through and out of the body in participants with a moderate reduction of kidney function compared to matched participants with normal kidney function. To answer this, the researchers will compare: - the (average) total level of BAY2395840 in the blood (also known as AUC), and - the (average) highest level of BAY2395840 in the blood (also known as Cmax) between the two groups of participants. The participants do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies in people with inflammatory conditions. As some people with these conditions may also have kidney problems, this study is done in participants with moderate reduction of kidney function to characterize the use of BAY2395840 in this patient group. All participants will take a single dose of BAY2395840 as tablets. Each participant will be in the study for up to 5 weeks. They will stay in-house for 4 days, including one treatment day. In addition, one visit before and one visit after the in-house phase to the study site is planned.