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Healthy Volunteers clinical trials

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NCT ID: NCT05118113 Recruiting - Healthy Volunteers Clinical Trials

Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

SMART101-HV1
Start date: April 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.

NCT ID: NCT05117294 Completed - Healthy Volunteers Clinical Trials

A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People

Start date: December 21, 2021
Phase: Phase 1
Study type: Interventional

This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different groups of people. This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups are different in Part 1. In each part, people in the study will stay in a research unit for 6 days and 5 nights. Later, they will return to the research unit for 1 check-up. In Part 1, people whose kidneys work normally and people whose kidneys work very poorly (severe renal impairment) can take part. If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work well (mild or moderate renal impairment) can take part. In both parts of the study, people who can take part will be admitted to the research unit. The next day they will take tablets of ASP0367 just once. People will give blood and urine samples at various times during their stay. They will have their vital signs (heart rate and blood pressure) checked regularly. People will also have ECGs to check their heart rhythm. They will be asked if they have any medical problems. After 6 days, provided all the checks have been done and there are no medical problems, people in the study will leave the research unit. People will return to the research unit for 1 check-up. This will be between 9 and 11 days after their last blood sample was taken during their previous stay in the unit. The check-up will include a physical exam, a check of people's vital signs (heart rate and blood pressure), and blood tests. Also, people will have an ECG and be asked if they have had any medical problems.

NCT ID: NCT05116969 Withdrawn - Healthy Volunteer Clinical Trials

A Phase 1 Study of PTX-35 in Healthy Volunteers

Start date: November 24, 2021
Phase: Phase 1
Study type: Interventional

A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers

NCT ID: NCT05108961 Completed - Healthy Volunteers Clinical Trials

Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

Bisprectral2
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.

NCT ID: NCT05108259 Recruiting - Healthy Volunteers Clinical Trials

To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects

Start date: March 30, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to demonstrate pharmacokinetic (PK) equivalence of PBP1502 to the European (EU) and American (US) Humira reference products, following a single subcutaneous (SC) dose of 40 mg in healthy volunteers.

NCT ID: NCT05105698 Not yet recruiting - Healthy Volunteers Clinical Trials

Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg

Start date: January 1, 2022
Phase: Phase 1
Study type: Interventional

A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers

NCT ID: NCT05103878 Completed - Healthy Volunteers Clinical Trials

A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects

Start date: June 24, 2020
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending doses of BT051 in healthy male or female volunteers aged 18 to <50 years. A total of 50 subjects will be randomized to receive a single oral dose of BT051 or matching placebo in a ratio of 4 active:1 placebo in 5 ascending dose cohorts (10 subjects per cohort) at active dose levels of 100mg, 300mg, 700mg, 1500mg or 3500mg. The study Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) occurred in a cohort through Day 3, as well as review cumulative safety data for all previous cohorts and any available pharmacokinetic (PK) data before proceeding to dosing in the next cohort.

NCT ID: NCT05103241 Completed - Healthy Volunteers Clinical Trials

A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers

Start date: October 26, 2021
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational administration.

NCT ID: NCT05102552 Completed - Healthy Volunteer Clinical Trials

Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects

Start date: October 19, 2021
Phase: Early Phase 1
Study type: Interventional

Randomized, Open-Label, Multiple Dose study to evaluate the relative bioavailability of Treatment A, Treatment B, and Treatment C

NCT ID: NCT05102136 Completed - Healthy Volunteers Clinical Trials

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers

Start date: October 27, 2021
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants The secondary objectives of the study are to: - Evaluate the effects of single doses of REGN9933 on intrinsic/common pathway coagulation - Evaluate the effects of single doses of REGN9933 on extrinsic/common pathway coagulation - Characterize the drug concentration profiles and pharmacokinetic (PK) following single escalating doses of REGN9933 - Characterize the concentration profiles of total FXI following single escalating doses of REGN9933 - Assess the immunogenicity of single doses of REGN9933