Clinical trials: Tolerability
Healthy Volunteers
Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.
- Trial name
- NCT04753710
- Testing
- Ocular gel
- Where
- Austria
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sintetica SA
Healthy, Type 2 Diabetes Mellitus (T2D)
A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants
The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants.
- Trial name
- NCT06869018
- Testing
- LY3549492
- Where
- 4 sites in Japan
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Study of Danavorexton in Anesthetized Adults
The aims of the study are: to assess the safety profile of danavorexton when it is administered with anesthetics. to learn what effect danavorexton has on anesthetized adults.
- Trial name
- NCT05025397
- Testing
- Danavorexton, Propofol, Sevoflurane
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Takeda
COVID-19; and High Infection Risk of SARS-CoV-2
Tolerability,Safety,Pharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody (JS016) for Injection in Chinese Health Subjects
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese…
- Trial name
- NCT04441918
- Testing
- JS016 (anti-SARS-CoV-2 monoclonal antibody)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
SARS-CoV-2
Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults
The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
- Trial name
- NCT04715997
- Testing
- GX-19N
- Where
- 5 sites in South Korea
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Genexine, Inc.
Healthy
Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects
Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet
- Trial name
- NCT02183090
- Testing
- Meloxicam ampoule, Meloxicam tablet
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Participants
Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects
This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of single oral ascending doses of E2027, will be administered to healthy adult participants to determine the maximum tolerated dose…
- Trial name
- NCT02415790
- Testing
- E2027
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Acute Gouty Arthritis, Acute Pain
Treatment of Topical Ketorolac Gel in Acute Gouty Flare
This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac…
- Conditions
- Acute Gouty Arthritis, Acute Pain, Gout Flare
- Trial name
- NCT06273813
- Testing
- Ketorolac Tromethamine 15 MG/ML, Ketorolac Tromethamine
- Where
- 2 sites in Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novilla Pharmaceuticals
Healthy
Study of Safety, Tolerability and PK, PD of HPG1860 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1860 orally administered in…
- Trial name
- NCT04480697
- Testing
- HPG1860
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Hepagene (Shanghai) Co., Ltd.
Healthy
A First-in-Human Safety Trial of MTX-463
A randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of single and multiple ascending doses of MTX-463 administered in…
- Trial name
- NCT06401213
- Testing
- MTX-463
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Mediar Therapeutics
Smoking Cessation
A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.
- Trial name
- NCT00463918
- Testing
- varenicline
- Where
- 16 sites in United States, United Kingdom
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Pfizer
Influenza
Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus
The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal antibody against influenza A viruses.
- Trial name
- NCT01406418
- Testing
- CR6261 2 mg/kg, CR6261 5 mg/kg, CR6261 15 mg/kg
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Diabetes, Diabetes Mellitus, Type 2
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01597713
- Testing
- NNC 0148-0000-0362, insulin glargine
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects
Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.
- Trial name
- NCT01217918
- Testing
- 1 mg, 5 mg, 10 mg
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax
Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels
Study to investigate the safety profile of AZD4721 after single doses at different dose levels
- Trial name
- NCT01889160
- Testing
- AZD4721 Solution, AZD4721 Suspension
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Health, Subjective
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants
This study plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone.
- Trial name
- NCT07345364
- Testing
- SIM0811
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy
Safety, Tolerability and Pharmacodynamics of BIIF 1149 BS in Healthy Young Male Volunteers
The objective of the present study is to obtain information about the safety and tolerability of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain…
- Trial name
- NCT02199899
- Testing
- BIIF 1149 BS - single rising doses
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Long QT Syndrome
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects.
- Trial name
- NCT05906732
- Testing
- LQT-1213, Dofetilide 250 μg Cap
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Homocystinuria
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
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.
- Trial name
- HCU (NCT05462132)
- Testing
- SYNB1353
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Synlogic
Growth Hormone Deficiency
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers.
- Trial name
- NCT02418767
- Testing
- MOD-4023
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
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