Clinical trials: Tolerability
Healthy
A Safety, Tolerability, PD and PK Study in Healthy Adults
The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
- Trial name
- NCT02211625
- Testing
- Open-label TRV734 125 mg, TRV734 blinded, Oxycodone IR 10 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Trevena Inc.
Schizophrenia or Schizoaffective Disorder
Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects.
- Trial name
- MAD (NCT02504476)
- Testing
- AMG 581, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Amgen
Hypertension
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component…
- Trial name
- IDCV (NCT02343250)
- Testing
- Cilnidipine/Valsartan, Cilnidipine+Valsartan
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Dyslipidemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects
This study will be a randomized, single-blind, placebo-controlled, single-ascending dose (SAD), sequential group study. It is a SAD study in healthy Non-Asian subjects (Part 1) and healthy Japanese subjects (Part 2) to assess the…
- Trial name
- NCT04055168
- Testing
- AZD6615
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers, Tauopathies
A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants
This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo.
- Conditions
- Healthy Volunteers, Tauopathies, Alzheimer Disease
- Trial name
- NCT05344989
- Testing
- APNmAb005
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- APRINOIA Therapeutics, LLC
Influenza
Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults
Background: The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection.
- Trial name
- NCT04579250
- Testing
- VRC-FLUNPF0103-00-VP (H10ssF-6473)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Schizophrenia
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
This 4-panel study will evaluate the safety, tolerability, pharmacokinetics (PK) and corrected QT interval (QTc) effect of MK-8189 versus placebo, as monotherapy in healthy participants (Panel A) including those of Japanese…
- Trial name
- MDCS (NCT03565068)
- Testing
- MK-8189, Background AAP Therapy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
- Trial name
- NCT06360874
- Testing
- ND-003 40mg, ND-003 80mg, ND-003 160mg
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Shenzhen NewDEL Biotech, Co., Ltd
Influenza
Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses
The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.
- Trial name
- NCT01756950
- Testing
- 2 mg/kg CR8020, 5 mg/kg CR8020, 15 mg/kg CR8020
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Health Adult Subjects, Obesity & Overweight
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.
- Trial name
- NCT07675590
- Testing
- TIX100
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- TIXiMED, Inc.
Healthy Volunteers (no Disease Condition Under Study)
A Phase 1, First-in-Human Trial of BLN-481in Healthy Adult Participants
This Phase 1 first-in-human study will evaluate BLN-481 in healthy adults. Participants will receive BLN-481 or placebo. Part 1 evaluates single ascending intravenous (IV) doses (SAD) and optional subcutaneous (SC) doses.
- Trial name
- NCT07903064
- Testing
- BLN-481
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Beeline Medicines Corporation
Healthy
Trial of JMKX003801 in Healthy Participants
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult…
- Trial name
- NCT06549309
- Testing
- JMKX003801
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Jemincare
Chronic Low Back Pain
Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects
The study evaluates the safety, tolerability and pharmacokinetics of single and repeated doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical positive comparative patch.
- Trial name
- NCT03997734
- Testing
- AB001, oral capsule, positive comparative patch
- Where
- China
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Frontier Biotechnologies Inc.
Healthy
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
- Trial name
- NCT00822341
- Testing
- TG-0054
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GPCR Therapeutics, Inc.
Healthy
Phase 1, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of mGlu5 NAM HTL0014242
This is the first time HTL0014242 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when HTL0014242 is administered orally as single doses to healthy subjects.
- Trial name
- NCT03785054
- Testing
- HTL0014242
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Gaucher Disease
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers
Primary Objective: To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.
- Trial name
- NCT04787887
- Testing
- Abcertin, EU-sourced Cerezyme
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ISU Abxis Co., Ltd.
Bipolar Depression, Bipolar Disorder
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models. This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses…
- Trial name
- NCT00908154
- Testing
- GSK1014802
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
- Trial name
- NCT05058105
- Testing
- FL058 500mg and Meropenem 1000mg（ IV 120min）, FL058 1000mg（ IV 120min）, Meropenem 1000 mg （ IV 120min）
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
HIV Infections
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV…
- Trial name
- NCT04824131
- Testing
- Oral cabotegravir (CAB), CAB LA, Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
- Where
- 3 sites in South Africa, Uganda and 1 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer, Type 2 Diabetes
A Research Study of a New Medicine, NNC9733-0001, in Healthy Participants and Participants With Type 2 Diabetes
This study is testing a new medicine that might help treat people with type 2 diabetes. The study is conducted to see if the new medicine can lower high sugar levels in the blood.
- Trial name
- NCT07270731
- Testing
- NNC9733-0001
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
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