Clinical trials: Safety Study
Autoimmune Diseases, Multiple Sclerosis
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
- Trial name
- NCT05853835
- Testing
- LPX-TI641
- Where
- 2 sites in United States, Jordan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- LAPIX Therapeutics Inc.
Healthy
A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult participants.
- Trial name
- NCT05481333
- Testing
- REGN7999
- Where
- Belgium
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
HIV Infections
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal…
- Trial name
- NCT00613249
- Testing
- Dapivirine Gel 4750, 0.05%, 2.5g, Dapivirine Gel 4789, 0.05%, 2.5g
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Dyslipidaemias
A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.
This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.
- Trial name
- NCT00783549
- Testing
- an undetermined dose of GSK1292263, ascending dose of GSK1292263
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative…
- Trial name
- NCT03464058
- Testing
- BOS172767 tablets, BOS172767 liquid capsules, BOS172767 micronized capsules
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Pharmaceuticals
Healthy
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
- Trial name
- NCT03802526
- Testing
- NVP-1805-R1, NVP-1805-R2, NVP-1805-R1 and NVP-1805-R2
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- NVP Healthcare
Rectal Injury
A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury
The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.
- Trial name
- NCT05939778
- Testing
- TH-SC01(Umbilical cord mesenchymal stem cells)
- Where
- China
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Jinling Hospital, China
Papillomavirus Infections
A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)
Researchers want to learn if V503 (also called the 9-valent human papillomavirus [9vHPV] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously…
- Trial name
- NCT07785843
- Testing
- V503
- Where
- China
- Volunteers
- 930 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes
UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes
The aim is to Investigate the safety and efficacy of Portal vein infusion Allogeneic Human umbilical cord mesenchymal stem cells combined with Allogeneic islet transplantation for the treatment of diabetes
- Trial name
- NCT06751199
- Testing
- human umbilical cord mesenchymal stem cells, allogeneic islet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Shanghai Changzheng Hospital
Varicella (Chickenpox), Chickenpox Vaccine
A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up…
- Trial name
- NCT07054099
- Testing
- MG1111 (Barycela inj.), VARIVAX™
- Where
- Thailand
- Volunteers
- 474 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Healthy Volunteers
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.
- Trial name
- NCT00783484
- Testing
- PF-03716539, Midazolam, Midazolam + PF-03716539 (100 mg)
- Where
- Belgium
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment, Hepatic Impairment
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild…
- Trial name
- NCT05731804
- Testing
- SIM0417 600 mg; Ritonavir100 mg, SIM0417 375 mg; Ritonavir100 mg, SIM0417 750 mg; Ritonavir100 mg
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Type 2 Diabetes Mellitus
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
- Trial name
- NCT01042106
- Testing
- DSP-8658
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sumitomo Pharma America, Inc.
Influenza
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
The purpose of the study is to compare the safety of \& immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix]…
- Trial name
- NCT00693706
- Testing
- Trivalent influenza vaccine GSK 138842A, Fluarix
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria,Falciparum
Safety and Efficacy of R0.6C Vaccine
This is a first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant…
- Trial name
- STOP-TRANS (NCT04862416)
- Testing
- R0.6C transmission blocking vaccine
- Where
- Netherlands
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Infections, Papillomavirus
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.
- Trial name
- NCT01153906
- Testing
- Data collection
- Where
- United States
- Volunteers
- 1,516 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment, Cirrhosis
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of…
- Trial name
- NCT05484206
- Testing
- VIR-2218, VIR-3434
- Where
- 4 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Heart Failure
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Kidney Disease and in Age-, Weight- and Gender-matched Healthy Participants
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body.
- Trial name
- NCT04722484
- Testing
- Vericiguat (BAY1021189)
- Where
- Germany
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Bayer
Single Ascending Dose, Healthy Subjects
A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.
This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy…
- Trial name
- NCT07190716
- Testing
- GR2301 injection
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
HIV/AIDS, HIV Infections
Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
The purpose of this study is to compare different ways to deliver the couples HIV Testing and Counseling (CHTC) intervention that is suited for adolescents and young adults.
- Trial name
- WeTestATN156 (NCT04289116)
- Testing
- We Test, IHTC
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Florida State University
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