Clinical trials: Safety and Tolerability
Hepatitis C, Chronic
480 STUDY: Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)
The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™…
- Trial name
- 480S (NCT00953589)
- Testing
- ribavirin
- Where
- 15 sites in Bulgaria, Israel and 1 more
- Volunteers
- 74 people
- Sponsor
- Biolex Therapeutics, Inc.
Asthma
Safety, Efficacy, PK, and PD Characteristics of Orally Inhaled SB010 in Male Patients With Mild Asthma (Multiple Dose)
Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent airway obstruction.
- Trial name
- NCT01743768
- Testing
- SB010
- Where
- 7 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Sterna Biologicals GmbH & Co. KG
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects.
- Trial name
- NCT07230418
- Testing
- HRS-3095 Tablet
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Hypercholesterolemia
Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
Primary Objective: Injection Site Tolerability Secondary Objectives: To assess the safety profile of alirocumab SAR236553 (REGN727) To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
- Trial name
- NCT01448239
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolemia
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).
- Trial name
- NCT03455777
- Testing
- AKCEA-ANGPTL3-LRX
- Where
- Canada
- Sponsor
- Akcea Therapeutics
EPP, XLP
Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
To evaluate the long-term safety and tolerability of oral dersimelagon.
- Trial name
- NCT05005975
- Testing
- MT-7117
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 286 people
- Sponsor
- Tanabe Pharma America, Inc.
Overweight and/or Obesity
Semaglutide Delivered Epi-Intradermally by Microarray Patch (VX-201) Versus Subcutaneous Administration in Healthy Overweight and Obese Participants
VX-201-101 is a first-in-human Phase 1 clinical study evaluating VX-201, a needle-free microneedle (MN) array patch (MAP) that delivers semaglutide through the skin as an alternative to subcutaneous (SC) injection.
- Trial name
- NCT07673900
- Testing
- VX-201, semaglutide SC
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Terrestrial Bio, Inc.
Atherosclerosis
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease…
- Trial name
- NCT01258907
- Testing
- MLDL1278A, statin, stable dose
- Where
- 24 sites in United States, Canada
- Volunteers
- 147 people
- Sponsor
- Genentech, Inc.
Still's Disease, Adult-Onset
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy…
- Trial name
- NCT05715736
- Testing
- APB-R3
- Where
- Australia
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Chronic Hepatitis C Infection
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267…
- Trial name
- NCT01563536
- Testing
- ABT-267, ABT-450, ABT-333
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Shock, Septic
Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.
- Trial name
- ASTONISH (NCT04055909)
- Testing
- nangibotide low dose, nangibotide high dose
- Where
- 43 sites in Belgium, Denmark and 4 more
- Volunteers
- 355 people
- Sponsor
- Inotrem
Glioblastoma, MGMT-Unmethylated Glioblastoma
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase…
- Trial name
- NCT03250299
- Testing
- Microtubule-Targeted Agent BAL101553, Radiation Therapy
- Where
- 8 sites in United States
- Volunteers
- 26 people
- Sponsor
- Basilea Pharmaceutica
Hypertension With Renal Dysfunction
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
- Trial name
- NCT01593787
- Testing
- LCZ696
- Where
- 13 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteer Study
Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects
This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
- Trial name
- NCT05881993
- Testing
- CBP-4888
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Comanche Biopharma
Diabetic Macular Edema
Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.
- Trial name
- NCT00320814
- Testing
- VEGF Trap-Eye
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Regeneron Pharmaceuticals
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.
- Trial name
- NCT03896945
- Testing
- AVP-786
- Where
- 72 sites in United States, Bulgaria and 2 more
- Volunteers
- 136 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Essential Tremor
A Pilot Efficacy and Safety Study of ST101 in Essential Tremor
This study will look at the ability of ST101 to treat symptoms in subjects with Essential Tremor. This study will also examine the safety and tolerability of the drug.
- Trial name
- NCT01332695
- Testing
- ST101
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Sonexa Therapeutics, Inc.
Chikungunya Virus
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
- Trial name
- NCT03325075
- Testing
- VAL-181388
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
DM1, Muscular Dystrophies
Extension of AOC 1001-CS1 (MARINA) Study in Adult Myotonic Dystrophy Type 1 (DM1) Patients
AOC 1001-CS2 (MARINA-OLE) (NCT05479981) is a Phase 2 extension of the AOC 1001-CS1 (MARINA) (NCT05027269) study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple-doses of AOC 1001…
- Conditions
- DM1, Muscular Dystrophies, Myotonic Dystrophy, Myotonic Dystrophy 1
- Trial name
- MARINA-OLE (NCT05479981)
- Testing
- AOC 1001
- Where
- 8 sites in United States
- Volunteers
- 37 people
- Sponsor
- Avidity Biosciences, Inc.
Healthy Volunteer
A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants.
- Trial name
- NCT05148481
- Testing
- BIIB104
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Biogen