Clinical trials: Safety Study
Birth Outcomes, Safety
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart).
- Conditions
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Trial name
- NCT06503900
- Testing
- mRNA COVID-19 vaccine, IIV4 (quadrivalent inactivated influenza vaccine)
- Where
- 6 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Duke University
Caregivers, Decision Making
"Safety in Dementia": An Online Caregiver Intervention
In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.
- Conditions
- Caregivers, Decision Making, Alzheimer Disease, Social Media
- Trial name
- NCT05173922
- Testing
- Safety in Dementia
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Safety, Preschool Age Children
Empowering Preschool Children With Personal Safety Skills
Preschool children are vulnerable to preventable accidents due to limited hazard awareness. This randomized controlled study evaluated the effectiveness of a Multiple Intelligences Theory-based Personal Safety Education Program…
- Conditions
- Safety, Preschool Age Children, Self Administration, Education Entertainment Intervention
- Trial name
- NCT07454538
- Testing
- Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Karabuk University
Safety and Tolerability, Healthy Volunteers
Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab)
Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially…
- Trial name
- NCT06331884
- Testing
- AK1967 (Procizumab)
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- 4TEEN4 Pharmaceuticals GmbH
Safety, Pharmacokinetics
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal.
- Conditions
- Safety, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT06072170
- Testing
- Kratom
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Altasciences Company Inc.
Safety, Tolerability
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.
- Conditions
- Safety, Tolerability, Ocular Surface, Ocular Comfort
- Trial name
- PRO-172 (NCT04693429)
- Testing
- Bepotastine Besilate
- Where
- Mexico
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Motor Vehicle Injury, Safety Issues
Safety-Enhancing Motor Vehicle Child Safety Seat
This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle.
- Trial name
- NCT06384989
- Testing
- Child restraint system with load leg feature
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Minnesota HealthSolutions
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Safety Issues, Injuries
An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors.
- Conditions
- Safety Issues, Injuries, Firearm Injury
- Trial name
- NCT04622943
- Testing
- firearms safety, nutrition
- Where
- United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Safety Issues
A Phase 1 Study of EXT608 in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants.
- Trial name
- NCT05408663
- Testing
- EXT608
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Extend Biosciences Inc.
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
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
Drink Too Much, Drinking, Binge
Group-based Intervention for Club Patrons
The purpose of this study is to develop and test a group-based strategy for encouraging groups of young adults who are engaged in party behaviors at nightclubs to intervene with each other to reduce harms associated with overuse…
- Conditions
- Drink Too Much, Drinking, Binge, Drunk, Drug Use
- Trial name
- NCT03652688
- Testing
- Nightlife Safety Plans (NSP), Fire Safety
- Where
- 2 sites in United States
- Volunteers
- 959 people, healthy volunteers welcome
- Sponsor
- Pacific Institute for Research and Evaluation
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
None - Study is to Determine Safety in Healthy Participants
A Phase I Study to Evaluate LSALT Peptide
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants
- Trial name
- NCT03772678
- Testing
- LSALT peptide, 0.9% Saline
- Where
- Australia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Arch Biopartners Inc.
Safety Issues, Tolerance
Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers
Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766 in Healthy participants.
- Trial name
- NCT05105243
- Testing
- CVN766
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Cerevance
Child Safety Seat Harness Tension
Minnesota HealthSolutions Cellular Car Seat Study
The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed…
- Trial name
- NCT05552027
- Testing
- CCS System- Prototype, CCS System- Control
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Minnesota HealthSolutions
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
COVID-19, Pharmacokinetics
Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
This is a phase I randomized, placebo-controlled, single site to assess the local and systemic safety of intranasal Q-Griffithsin (Q-GRFT) after 14 doses in approximately 45 adult participants.
- Conditions
- COVID-19, Pharmacokinetics, Safety
- Trial name
- NCT05180500
- Testing
- Q-Griffithsin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sharon Hillier
Patient Safety, Manipulation, Spinal
(MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation
To increase patient safety culture in spinal manipulation therapy (SMT) this study will assess the ability to implement an active surveillance reporting system for a chiropractic teaching clinic and determining preliminary…
- Trial name
- MIST1 (NCT03412097)
- Testing
- active surveillance
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Parker University