Clinical trials: Tolerability
Migraine
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients.
- Trial name
- NCT01723514
- Testing
- Erenumab
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Chinese Volunteers
An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers
The subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And…
- Trial name
- NCT04627116
- Testing
- Tecarfarin
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Healthy
Study Evaluating SCA-136 Tolerability With Dose Titration and Food
To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.
- Trial name
- NCT00420706
- Testing
- SCA-136
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Paroxysmal Nocturnal Hemoglobinuria
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
Primary objective The tolerability and safety of SAR443809 Secondary The PK parameters of SAR443809 The PD activity of SAR443809 The immunogenicity of SAR443809
- Trial name
- NCT06326814
- Testing
- Humanized anti-Factor Bb monoclonal antibody
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanofi
Glomerulonephritis
Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency
The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function.
- Trial name
- NCT05505955
- Testing
- HRS-5965
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Alzheimer Disease, Alzheimer Disease (AD)
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection.
- Conditions
- Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease
- Trial name
- DU-PRISM (NCT07142278)
- Testing
- DUVAX 200 µg, DUVAX 400 µg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nuravax, Inc.
Chronic Hepatitis c
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.
- Trial name
- NCT03811678
- Testing
- Kangdaprevir Sodium Tablet
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Volunteers
SAD and MAD Study With IV and SC Doses of ARGX-117
This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117…
- Trial name
- ARGX-117 (NCT04532125)
- Testing
- ARGX-117, ARGX-117 + rHuPH20, ARGX-117 PH20 SC
- Where
- Netherlands
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
- Trial name
- NCT05813717
- Testing
- BMS-986325
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Cutaneous Leishmaniasis
Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).
- Trial name
- NCT00121849
- Testing
- Leish-111f + MPL-SE vaccine
- Where
- Colombia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Healthy
Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject
The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 in healthy male subjects.
- Trial name
- NCT01161355
- Testing
- AZD9668
- Where
- 2 sites in United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
- Trial name
- NCT02174835
- Testing
- AVP-786, AVP-923
- Where
- Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hepatitis B, Healthy
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication.
- Trial name
- NCT04297917
- Testing
- ChAdOx1-HBV
- Where
- 4 sites in United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Barinthus Biotherapeutics
Safety After Oral Intake
Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
The goal of this clinical trial is to learn if drug MDI2517 is safe and to learn more about its drug effects in healthy participants.
- Trial name
- NCT07220889
- Testing
- MDI-2517 800mg, MDI-2517 1600mg, MDI-2517 2400mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- MDI Therapeutics, Inc.
SARS-CoV-2
A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in Adults
This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001/-1b, 28 days apart.
- Trial name
- NCT04591184
- Testing
- Covigenix VAX-001
- Where
- 4 sites in Burkina Faso, Canada and 2 more
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Entos Pharmaceuticals Inc.
Healthy Volunteer
A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
- Trial name
- NCT02427243
- Testing
- Crenezumab
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo
This is a pilot study of the safety, tolerability, and effectiveness of Halo to prevent acute upper respiratory illness and respiratory virus infections.
- Trial name
- NCT02644135
- Testing
- Halo Oral Spray
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Mood Disorder
Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar Tients From Valproic Acid to Depakote ER
The purpose of this study is to compare compliance, tolerability, effectiveness, and side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER.
- Trial name
- NCT00211250
- Testing
- Valproic Acid and Depakote ER
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Joliet Center for Clinical Research
Feasibility, Safety and Tolerability of Device
A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier
The goal of this interventional feasibility study is to learn about the feasibility, acceptability, and safety of a novel myofunctional pacifier in infants from birth to 6 months of age.
- Trial name
- NCT07793058
- Testing
- BREATHE myofunctional pacifier
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Keystone OrthotropiX
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