Clinical trials: Safety and Tolerability
Safety and Tolerability in Healthy Volunteers
A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects
This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers.
- Trial name
- NLY01-H1 (NCT03672604)
- Testing
- NLY01
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Neuraly, Inc.
Safety and Tolerability
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods.
- Trial name
- NCT03307512
- Testing
- inhaled human insulin, Insulin Lispro (Humalog U-100)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dance Biopharm Inc.
Safety and Tolerability
Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
- Trial name
- NCT03853421
- Testing
- Sevuparin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Modus Therapeutics AB
Safety and Tolerability of EGT0001474 in Healthy Volunteers
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
- Trial name
- NCT00854113
- Testing
- EGT0001474
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Theracos
Safety, Tolerability
Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.
This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects.
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Trial name
- NCT02107885
- Testing
- DS-1971
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Safety, Tolerability
A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.
This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT02512575
- Testing
- AZD9567 Monohydrat, Prednisolone
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Safety, Tolerability
Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206
A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor antagonist in healthy male subjects.
- Conditions
- Safety, Tolerability, Pharmacodynamics, Pharmacokinetics
- Trial name
- NCT01954589
- Testing
- ACT-462206 5 mg, ACT-462206 25 mg, ACT-462206 100mg
- Where
- Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects
Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group).
- Trial name
- NCT01954615
- Testing
- 5 mg ACT-281959 prodrug formulation I (Group A), 20 mg ACT-281959 prodrug formulation I (Group B), ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
- Where
- France
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Safety and Tolerability in Healthy Subjects
A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
This study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4…
- Trial name
- NCT03239379
- Testing
- BNZ132-1-40
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bioniz Therapeutics
Safety and Tolerability
DP13 SAD & MAD in Healthy Male Subjects
Primary Objectives: 1. To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects 2.
- Trial name
- NCT03046589
- Testing
- DP13
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Damian Pharma AG
Safety, Tolerability
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Healthy Subjects
- Trial name
- NCT02484729
- Testing
- AZD9977, oral suspension, AZD9977, oral solution
- Where
- United Kingdom
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Safety and Tolerability
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as bacterial pneumonia.
- Trial name
- NCT01907867
- Testing
- Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- MerLion Pharmaceuticals GmbH
Safety, Tolerability
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT02209506
- Testing
- MLN3126
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Takeda
Safety and Tolerability of Iloperidone
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
- Trial name
- NCT01495169
- Testing
- iloperidone (oral tablet)
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Vanda Pharmaceuticals
Advanced Solid Malignancy,, Safety and Tolerability,
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
- Conditions
- Advanced Solid Malignancy,, Safety and Tolerability,, Pharmacokinetics, Pharmacodynamics,, Tumour Response,
- Trial name
- OAK (NCT01895946)
- Testing
- AZD5363
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Safety, Tolerability
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects
The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Cancer
- Trial name
- NCT02054754
- Testing
- Dexanabinol Dose Level 1, Dexanabinol Dose Level 2, Dexanabinol Dose Level 3
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- e-Therapeutics PLC
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects
The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Safety and Tolerability in Elderly
- Trial name
- NCT01657890
- Testing
- isavuconazole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Safety,, Tolerability,
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses AZD8848 in Healthy Subjects
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD8848 in healthy subjects.
- Conditions
- Safety,, Tolerability,, Healthy Subjects
- Trial name
- NCT01818869
- Testing
- AZD8848
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Cardiodynamics, Safety
Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy…
- Conditions
- Cardiodynamics, Safety, Tolerability, Pharmacokinetics
- Trial name
- NCT02206204
- Testing
- selexipag, moxifloxacin
- Where
- United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Actelion
Safety, Tolerability
A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans
The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through…
- Conditions
- Safety, Tolerability, Pharmacokinetics of ASP7962
- Trial name
- NCT01981928
- Testing
- ASP7962
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.