62 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
This study will investigate the efficacy, safety, tolerability, and pharmacokinetics of RO7017773 in participants aged 15-45 years who have been diagnosed with ASD with a score of \>/=50 on the Wechsler Abreviated Scale of Intelligence (WASI-II).
The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>Ý 65 years with OAB.
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of \>/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of \>/= 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted for socialization.
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of SHP465 in children aged 4 to 5 years with ADHD after multiple daily doses of 6.25 milligram (mg) SHP465
The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at 6.25 milligram (mg) in children aged 4 to 12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.
To evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (PK) of LNK-754 in male and female elderly volunteers after dosing with LNK-754 for 7 days and in subjects with mild Alzheimer's Disease after dosing with LNK-754 for 28 days.
The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754 as well as safety and tolerability in normal healthy male and female elderly volunteers
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.
The goal of this clinical trial is to learn about the safety (good or bad) of giving two AION-301 intravenous (IV) infusions, in adults with Stage 3 Chronic Kidney Disease (CKD). It will also help to learn if AION-301 reduces the symptoms of CKD and/or progression. The main questions it aims to answer are: * Do participants have medical problems (adverse events) after receiving two infusions of AION-301? * Do participants feel better (have reduced and/or delayed CKD symptoms)? * To learn about how AION-301 works in participants with CKD? Researchers will compare AION-301 to a placebo (a look-alike substance that contains no drug) to see if AION-301 works to treat Stage 3 CKD. Participants will: * Receive two infusions of AION-301 or placebo on two separate days (Day 0 and Day 4). * Receive oral vitamins at the clinic and to take at home for 90 days. * Visit the clinic for a minimum of 9 times, over 6 months for checkups and tests, but could be up to 12 times, over 24 months for checkups and tests.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.
The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.
This first-in-human clinical trial with a randomized, double-blind, placebo-controlled, dose-escalation study design is regarded as standard to test the safety, tolerability, and pharmacokinetics of KYN-5356. The study comprises 3 parts: Part 1: Single Ascending Dose study Part 2: Multiple Ascending Dose study Part 3: Food Effect study The aim of Parts 1 and 2 of the study is to evaluate the safety and tolerability following single and multiple ascending doses of KYN-5356. The secondary aim is to evaluate the pharmacokinetics (PK) of escalating single and multiple doses of KYN-5356. In Part 2, cerebrospinal fluid will be sampled to explore PK and pharmacodynamic effects of KYN-5356. The potential effect of food intake on the disposition of KYN-5356 following a single oral dose will be evaluated in Part 3. Part 3 is an open-label, randomized, 2 period, 2 sequence design.
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.
This will be a first time in human (FTIH) study in sickle cell diseases (SCD) participants. The FTIH study is planned to evaluate the safety, tolerability, and pharmacokinetics of GSK4172239D. The study will be composed of 3 periods for all participants (Screening, Treatment, and Follow up). Participants will be screened and, prior to first dose on Day 1, will be randomized to receive either GSK4172239D or placebo. GSK4172239D is a prodrug that is converted in vivo into GSK4106401. This study will be a single dose, dose-escalation study. The initial dosing for all cohorts will be staggered so that 2 participants will be dosed as sentinel participants. Provided there are no safety concerns in 48 hours (h), the remaining 6 participants scheduled for the cohort may be dosed. One selected cohort of participants will also receive an additional single dose of GSK4172239D (or matching placebo) under fed (high calorie and high fat) conditions after a washout period of a minimum of 20 days or 5 half-lives, whichever is longer, designated as the Food Effect Cohort.
This study is divided into two parts: Part A of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamic (PD) effect of a single intravenous (IV) infusion dose of GSK1070806 when administered to healthy participants of Japanese, Chinese and European/Caucasian ancestry. Part B of the study is an open label single cohort arm to assess the safety, tolerability, PK and PD effect of a single IV bolus low dose of GSK1070806 in healthy participants of European/Caucasian ancestry.
This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a 42-day follow-up period.
The primary objective of this study is to evaluate the safety, tolerability, and plasma pharmacokinetic (PK) of E2511 following multiple oral doses in healthy adult participants.
This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose levels and administration regimens are administered to healthy younger (ages 18 to 50), older (ages 50 to 64 years) and elderly (ages 65 to 80 years) male and female subjects. Up to 5 dose levels and/or administration regimens will be evaluated in up to 5 cohorts. Each cohort will include approximately 8 to 12 subjects randomized in a 3:1 ratio (PB2452:placebo).
The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.
The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5\*10\^10 viral particles (vp) or 1\*10\^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly Japanese subjects and healthy younger adult Japanese subjects.
This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 years
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL.
The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).