Clinical trials: Safety Issues
Safety Issues, Tolerance
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Trial name
- NCT05217732
- Testing
- ZX-7101A
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Zenshine Pharmaceuticals
GERD, Cardiac Event
Cardiac Safety of Lansoprazole and Domperidon Combination
The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name: Lasotab) in GERD patients…
- Conditions
- GERD, Cardiac Event, Safety Issues
- Trial name
- NCT03355170
- Testing
- Lansoprazole/Domperidone, Lansoprazole
- Where
- 16 sites in Turkey (Türkiye)
- Sponsor
- Neutec Ar-Ge San ve Tic A.Ş
Safety Issues
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.
- Trial name
- NCT05037227
- Where
- Indonesia
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Effect of Drug
Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients
- Trial name
- NCT06114641
- Testing
- Enoxaparin sodium injection
- Where
- 3 sites in Indonesia
- Volunteers
- 220 people
- Sponsor
- PT Bio Farma
Natural Conception, Label Comprehension
FERTI-LILY Safety Study
The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup.
- Conditions
- Natural Conception, Label Comprehension, Device Usability, Safety Issues
- Trial name
- NCT05529160
- Testing
- FERTI LILY Conception Cup
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Rosesta Medical BV
Healthy
A First-in-Human Study of BNZ132-1-40
This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.
- Trial name
- NCT03046459
- Testing
- BNZ132-1-40
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bioniz Therapeutics
Safety Issues, Tolerance
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
- Trial name
- NCT06189170
- Testing
- KP405
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Kariya Pharmaceuticals
Safety Issues, Immunogenicity
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
- Trial name
- NCT03460405
- Testing
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
- Trial name
- NCT03336593
- Testing
- Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Acquired Bleeding Disorder, Trauma
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
- Trial name
- NCT00124293
- Testing
- activated recombinant human factor VII
- Where
- 2 sites in United States, Canada
- Volunteers
- 63 people
- Sponsor
- Novo Nordisk A/S
Safety Issues, Pharmacokinetics
Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
- Trial name
- HTL0018318 (NCT03198624)
- Testing
- HTL0018318
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Safety Issues, Tolerance
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in…
- Conditions
- Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
- Trial name
- NCT05427253
- Testing
- C106 solution
- Where
- Sweden
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vicore Pharma AB
Premature Ejaculation, Erectile Dysfunction
The Safety of Dapoxetine/Tadalafil Combination Therapy
The purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil 30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
- Conditions
- Premature Ejaculation, Erectile Dysfunction, Safety Issues
- Trial name
- NCT03177746
- Testing
- Dapoxetine/Tadalafil 30/20 mg film coated tablet
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Neutec Ar-Ge San ve Tic A.Ş
Safety Issues
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.
- Trial name
- NCT03473236
- Testing
- GB002, Generic Dry Powder Inhaler
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Safety Issues
Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation.
- Trial name
- NCT03789539
- Testing
- LD Universal Influenza Vaccine Uniflu, HD Universal Influenza Vaccine Uniflu
- Where
- Russia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- VA Pharma Limited Liability Company
Safety Issues
Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers
This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers.
- Trial name
- NCT05004571
- Testing
- EQU-001
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Equilibre Biopharmaceuticals B.V.
Safety Issues
Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose…
- Trial name
- NCT07058779
- Testing
- SSS55
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Reproducibility of Results, Safety Issues
Non-Invasive Blood Test Cross-Validation Study
The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method.
- Trial name
- NCT03991637
- Testing
- Non-Invasive Comprehensive Metabolic Panel
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Joseph Allen Jr.
Safety Issues
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
- Trial name
- NCT04485481
- Testing
- ADX-914
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Q32 Bio Inc.
Safety Issues
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
The purpose of this study was to determine the safety and tolerability of PH100, a purified phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds 8,8'-bieckol, dieckol, and…
- Trial name
- NCT04335045
- Testing
- PH100 100mg, PH100 200mg, PH100 400mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Phloronol Inc.