Clinical trials: Tolerability
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
The purpose of this study is to: evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 evaluate the efficacy, safety, tolerability, PK…
- Trial name
- NCT06845202
- Testing
- ALN-4324
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
SARS-CoV-2
Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.
- Trial name
- NCT04480957
- Testing
- ARCT-021 Dose 1, ARCT-021 Dose 2, ARCT-021 Dose 3
- Where
- Singapore
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Arcturus Therapeutics, Inc.
Neoplasms, Glandular and Epithelial, Diphtheria
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and…
- Conditions
- Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough
- Trial name
- NCT00337428
- Testing
- Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF), Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF), Comparator: REPEVAX™ (Concomitant)
- Volunteers
- 843 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus (RSV)
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to <18 years of age at high risk for RSV disease, including those who are immunocompromised.
- Trial name
- NCT07839871
- Testing
- RSVpreF
- Where
- 2 sites in United States, Japan
- Volunteers
- 920 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects
Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal.
- Trial name
- NCT03704675
- Testing
- TEW-7197
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- MedPacto, Inc.
Healthy Volunteers
Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers.
- Trial name
- NCT01477619
- Testing
- Tasimelteon
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Subjects
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
- Trial name
- NCT01199965
- Testing
- MAP0004, IV DHE
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Allergan
Hypercholesteremia
The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection…
- Trial name
- NCT03634436
- Testing
- SHR-1209
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy Adult Subjects
ONO-7746 Study in Healthy Adult Subjects
The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.
- Trial name
- NCT00956371
- Testing
- ONO-7746
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Trial name
- NCT06625671
- Testing
- DB-2304, Prednisone
- Where
- 7 sites in United States, Australia
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- DualityBio Inc.
Inflammatory Bowel Diseases
Phase 1 Study for IPG11406 in Health Volunteer
A phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and food effect of orally administered IPG11406 in healthy adult…
- Trial name
- NCT06255834
- Testing
- IPG11406
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Obesity, Overweight
A Study of LY4329090 in Participants With Obesity or Overweight Who Are Otherwise Healthy
The main purpose of this study is to assess how well LY4329090 is tolerated and what side effects may occur in healthy participants with obesity or overweight.
- Trial name
- NCT07808073
- Testing
- LY4329090
- Where
- 3 sites in United States, Singapore
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Adult Participants
A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11
This is a randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts.
- Trial name
- NCT06707142
- Testing
- TBD11
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Multiple Sclerosis
Safety of Switching From Rituximab to Ocrelizumab in MS Patients
This is a prospective between and within group observational study to determine differences in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS) patients who have been administered at least…
- Trial name
- NCT02980042
- Testing
- Ocrelizumab, Rituximab
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Cystic Fibrosis, Mucociliary Clearance
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of repeated doses of GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the…
- Conditions
- Cystic Fibrosis, Mucociliary Clearance, Airway Hydration
- Trial name
- NCT00999531
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Renal Failure
A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
- Trial name
- NCT04237831
- Testing
- BMS-986259
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
First-In-Human Study of Apramycin
This is a first-in-human study to assess the safety, tolerability and pharmacokinetics of escalating single doses of apramycin. This trial will be conducted as a single ascending dose trial in up to 5 sequential dose cohorts…
- Trial name
- NCT04105205
- Testing
- Apramycin injection
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Juvabis AG
Cardiovascular
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
- Trial name
- NCT06238466
- Testing
- AZD1705
- Where
- 5 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Plaque Psoriasis
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult…
- Trial name
- NCT07024602
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Healthy, Drug Drug Interaction
Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects
Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4 inducer (Cohort 2, rifampin multiple dose) on the plasma PK…
- Trial name
- NCT04606537
- Testing
- Itraconazole, Rifampin, KBP-5074
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
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