508 Clinical Trials for Various Conditions
A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
Forty healthy adults (i.e., not recruited with respect to any particular diagnosis) are each alternately provided with supplemental oxygen and air via nasal cannula at about 6 Liters per Minute (LPM), while completing memory tests.
The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.
The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of casdatifan tablet in healthy adult volunteers.
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
AOC 1044-CS1 (EXPLORE44) is a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of AOC 1044 in healthy adult volunteers and participants with DMD mutations amenable to exon 44 skipping. Part A is a single dose design with multiple cohorts (dose levels) in healthy adult volunteers. Part B is a multiple-ascending dose design with 3 cohorts (dose levels) in participants with Duchenne.
This Phase 1, first-in-human, randomized, double-blinded, placebo controlled study is evaluating FB-001 in healthy volunteers (Part 1) and participants diagnosed with enteric hyperoxaluria (Part 2). Eligible participants receive investigational product and undergo safety monitoring, evaluations and subsequent follow-up after investigational product administration.
This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074 to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).
This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.
This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.
The primary objectives of the study are: * To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna mRNA-1273 * To evaluate the time interval required between REGN10933+REGN10987 administration and Moderna mRNA-1273 vaccination, to ensure no meaningful impact on vaccine-induced neutralizing antibody responses to SARS-CoV-2 The secondary objectives of the study are: * To quantify the alteration of antigen specificity of vaccine-induced SARS-CoV-2 antibody responses when administered with different dose regimens of REGN10933+REGN10987 * To evaluate the safety and tolerability of REGN10933+REGN10987 and Moderna mRNA-1273 vaccine when administered in close succession * To assess the concentrations of REGN10933 and REGN10987 in serum over time in participants who receive REGN10933+REGN10987 and Moderna mRNA-1273 vaccine * To evaluate the immunogenicity of REGN10933 and REGN10987 over time
KT-474 is an oral heterobifunctional small molecule IRAK4 degrader being developed for the treatment of interleukin-1 receptor (IL-1R)/toll-like receptor (TLR)-driven immune-inflammatory diseases. This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of KT-474 in healthy volunteers and patients with atopic dermatitis (AD) or hidradenitis suppurativa (HS). The effects of food on the absorption of KT-474 will also be evaluated in healthy volunteers.
Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.
This Phase 1a/b, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB8802 in healthy volunteers (HV) and subjects diagnosed with enteric hyperoxaluria (EH). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration. In Part 2, all evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., EH patient's home, hotel).
The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: * To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. * To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.
This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.
This is a single-center, double-blind, single-dose escalation study in healthy volunteers.
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
The primary objectives of this study were: * To assess the effect of a high-fat diet on the pharmacokinetics (PK) of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults * To assess the effect of a calcium supplement on the PK of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults
The primary objectives of this study are the following: * To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants. * To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants. * To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants. * To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.
The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.
The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.