Clinical trials: Safety and Tolerability
Safety and Tolerability in Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection in Healthy Chinese Subjects
To evaluate the safety, tolerability, and pharmacokinetics of SSS39 injection in healthy Chinese subjects
- Trial name
- NCT07057726
- Testing
- SSS39
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Advanced Solid Malignancy, Safety and Tolerability
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future.
- Conditions
- Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT01226316
- Testing
- AZD5363
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 285 people
- Sponsor
- AstraZeneca
Safety and Tolerability in Healthy Volunteers
Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers
The main aim of this study is to evaluate the safety and tolerability of the product administered, of 3 different doses. Safety will be evaluated by recording and assessing adverse events, vital signs, laboratory tests and ECG.
- Trial name
- DAO-MAX2024 (NCT06715163)
- Testing
- Dose 1 (42mg) of DAO, Dose 2 (84mg) of DAO, Dose 3 (210mg) of DAO
- Where
- Spain
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- AB Biotek
Safety and Tolerability
A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2…
- Trial name
- NCT06000891
- Testing
- ZP7570
- Where
- Germany
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Safety Issues, Tolerability
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and…
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT06847698
- Testing
- AVR-48
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AyuVis Research, Inc.
Efficacy, Safety
Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study
Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study to evaluate the efficacy, safety and tolerability of Ertugliflozin and Sitagliptin Con-initiation in patients with Type II…
- Conditions
- Efficacy, Safety, Tolerability
- Trial name
- CEASE (NCT05556291)
- Testing
- Combinations of Oral Blood Glucose Lowering Drugs
- Where
- 3 sites in Pakistan
- Volunteers
- 190 people
- Sponsor
- Getz Pharma
Safety, Tolerability
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
The goal is to establish the safety of administration of nasal foralumab to healthy volunteers in escalating doses to determine the dose at which immune effects are observed.
- Trial name
- NCT06879067
- Testing
- Foralumab Nasal
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Tiziana Life Sciences LTD
Safety and Tolerability
SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants
This is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers.
- Trial name
- NCT06453824
- Testing
- MDI-2517
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- MDI Therapeutics, Inc.
Safety, Tolerability
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Healthy Participants
- Trial name
- NCT05143905
- Testing
- AZD7503
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Safety and Tolerability
A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
The goal of this clinical trial was to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state.
- Trial name
- NCT06181760
- Testing
- Fenretinide
- Where
- Australia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Island Pharmaceuticals
Safety Issues, Pharmacokinetics
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong…
- Conditions
- Safety Issues, Pharmacokinetics, Drug Interaction, Tolerability
- Trial name
- NCT05633147
- Testing
- Linaprazan glurate, Drug drug interaction (DDI) - Clarithromycin (Part I), Drug drug interaction (DDI) - Midazolam (Part 2)
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Safety of the CytaCoat LIP Foley Catheter, Tolerability of the CytaCoat LIP Foley Catheter
Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter
The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.
- Trial name
- NCT06242600
- Testing
- Drainage of the bladder by indwelling Foley catheter
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- CytaCoat AB
Epithelial Ovarian Cancer, Efficacy
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.
- Conditions
- Epithelial Ovarian Cancer, Efficacy, Safety, Bone Mineral Density
- Trial name
- NCT06539091
- Testing
- Fluzoparib, Apatinib Mesylate
- Volunteers
- 51 people
- Sponsor
- Anhui Provincial Hospital
Safety, Tolerability
Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects
This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and pharmacokinetics (PK) of single and multiple ascending oral doses of AM1476 in healthy subjects.
- Trial name
- NCT04691115
- Testing
- AM1476
- Where
- United Kingdom
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- AnaMar AB
Safety Issues, Tolerability
SB17170 Phase1 Trial in Healthy Volunteer
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT05795192
- Testing
- SB17170
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- SPARK Biopharma
Safety, Tolerability, Pharmacokinetics of AEF0217
AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.
This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first.
- Trial name
- AEF0217-101 (NCT05170737)
- Testing
- AEF0217
- Where
- Spain
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Aelis Farma
Pharmacokinetics, Safety
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.
- Conditions
- Pharmacokinetics, Safety, Tolerability
- Trial name
- NCT05698095
- Testing
- 5-methoxy-N,N-dimethyltryptamine succinate salt
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Usona Institute
Safety and Tolerability
Phase 1 Clinical Study of JMKX003142 Tablets
Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects…
- Trial name
- NCT06079541
- Testing
- JMKX003142 will be administered orally
- Where
- China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Jemincare
To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD
An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With nAMD
To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.
- Trial name
- NCT06022744
- Testing
- LX109
- Volunteers
- 12 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates
Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
Background: People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles.
- Conditions
- Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- Trial name
- NCT03702231
- Testing
- Zoster Vaccine Recombinant, Adjuvanted
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)