Clinical trials: System Safety
COVID-19, SARS-CoV-2
Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)
The primary objective is to assess the safety and tolerability of samRNA vaccines GRT-R912, GRT-R914, and GRT-R918 when administered as prime and/or boost in healthy adult participants naïve to severe acute respiratory syndrome…
- Trial name
- NCT05435027
- Testing
- GRT-R912, samRNA-Spikebeta-TCE11, GRT-R914, samRNA-Spikebeta-TCE9, GRT-R918, samRNA-SpikeOmicron-N-TCE11
- Where
- 4 sites in South Africa
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Gritstone bio, Inc.
Diabetes Mellitus, Type 2
First Time in Human Study Using GSK2330672
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
- Trial name
- NCT01416324
- Testing
- 0.1 mg GSK2330672, 0.3 mg GSK2330672, 1 mg GSK2330672
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
Safety of VSL#3 in Adult Asthmatics
We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol.
- Trial name
- NCT00852124
- Testing
- VSL#3
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Healthy
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants
This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.
- Trial name
- NCT05428696
- Testing
- ALXN2080
- Where
- United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Adult Volunteers, Active Ulcerative Colitis
A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis
This Phase 1b/2a clinical development plan is focused on the use of NP-201 acetate injection to investigate the pharmacokinetics (PK), safety, efficacy, PD (pharmacodynamic) markers (Phase 1b) and tolerability of NP-201 acetate…
- Conditions
- Healthy Adult Volunteers, Active Ulcerative Colitis, Active Ulcerative Colitis (UC)
- Trial name
- NCT06681389
- Testing
- NP-201 acetate injection (Part A)
- Where
- Australia
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- NIBEC Co., Ltd.
Long QT Syndrome
Phase 1 Study of LQT-1213 in Healthy Adults
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD).
- Trial name
- NCT05759962
- Testing
- LQT-1213
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Kidney Diseases, Kidney Injury
Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound.
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Trial name
- NCT05777174
- Testing
- MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 5 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Hepatitis B, Infectious Disease
A Study in Healthy Volunteers
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers.
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Trial name
- NCT03596697
- Testing
- CRV431, TDF
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Meningococcal Disease, Meningococcal Meningitis
A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three…
- Trial name
- NCT01339923
- Testing
- rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine, Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
- Where
- 26 sites in Brazil, Hungary and 2 more
- Volunteers
- 1,409 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Asthma
A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)
To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.
- Trial name
- NCT00646789
- Testing
- Comparator: MK0633
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Autoimmune Diseases
Phase I Study of GSK2982772 in Japanese Healthy Male Participants
The study plans to enroll approximately 12 subjects. The main objective of the study is to assess the safety, tolerability and pharmacokinetics (PK) of the three times a day (TID), dosing of GSK2982772, in Japanese healthy male…
- Trial name
- NCT03590613
- Testing
- GSK2982772
- Where
- Japan
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen…
- Conditions
- Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer, Anal Cancer
- Trial name
- NCT06866574
- Testing
- Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli), Aluminum Adjuvant
- Where
- 4 sites in China
- Volunteers
- 9,300 people, healthy volunteers welcome
- Sponsor
- Xiamen University
SMA II, Cerebral Palsy
Paracetamol Study in Patients With Low Muscle Mass
To investigate the safety and toxicity related to paracetamol treatment in children and adults with respectively SMA and CP.
- Trial name
- NCT03648658
- Testing
- Paracetamol 120Mg/5mL Oral Suspension
- Where
- Denmark
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mette Cathrine Oerngreen
Sleep Initiation and Maintenance Disorders
Bioequivalence and Food Effect Study in Healthy Volunteers
The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.
- Trial name
- NCT00495274
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- Italy
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gastric Ulcer
To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
- Trial name
- NCT03291418
- Testing
- Naproxen sodium
- Where
- Canada
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Antibe Therapeutics Inc.
Nonalcoholic Steatohepatitis (NASH)
A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.
- Trial name
- NCT04913090
- Testing
- XZP-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B), XZP-5610 Tablet (for "Part C1")
- Where
- China
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Sleep Disorders
A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.
The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions…
- Trial name
- NCT01299597
- Testing
- Atorvastatin, Simvastatin, SB649868
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atopic Dermatitis
A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants
The goal of this intervention study is to evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HXN5003 in Healthy Participants.The main parameters it aims to answer are: 1.
- Trial name
- NCT07549750
- Testing
- HXN5003
- Where
- Australia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
Multiple Sclerosis, Relapsing-Remitting
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will enrol healthy volunteers and Part C (open-label) will enrol RRMS patients.
- Trial name
- NCT01808482
- Testing
- Part A: 100 mg/mL GSK2618960, Part B: Dose of GSK2618960 decided from Part A, Part C: Dose of GSK2618960 decided from Part A and B
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy…
- Trial name
- NCT05330455
- Testing
- GSK3965193, Bepirovirsen
- Where
- 14 sites in Canada, France and 4 more
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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