Clinical trials: Tolerability
Bioequivalence
Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women
Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects.
- Trial name
- NCT02592031
- Testing
- XM17, Gonal-f®, Zoladex®
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Merckle GmbH
Normal Healthy Volunteers
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults
This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adult participants.
- Trial name
- NCT02802631
- Testing
- Minocin (minocycline) for Injection
- Where
- Netherlands
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Infections, Respiratory
PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers
This is a first-in-human (FIH) study to explore the safety, tolerability and pharmacokinetics of PA after oral ascending dose administration to healthy male volunteers.
- Trial name
- PA (NCT04174937)
- Testing
- Potentiator of antibiotics (PA)
- Where
- Kazakhstan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
Parkinson's Disease
Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.
- Trial name
- NCT04165837
- Testing
- FB-101
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- 1ST Biotherapeutics, Inc.
Volunteers
Voclosporin in Healthy Japanese Volunteers
The study is a single-centre, double-blind, placebo controlled, randomized, ascending multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic profiles of voclosporin.
- Trial name
- NCT02949999
- Testing
- Voclosporin
- Where
- Philippines
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Aurinia Pharmaceuticals Inc.
Vaccines, Pneumococcal
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00366899
- Testing
- 13-valent pneumococcal conjugate vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 13 sites in Italy
- Volunteers
- 605 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial.
- Trial name
- NCT04919863
- Testing
- NTP42:KVA4
- Where
- United Kingdom
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- ATXA Therapeutics Limited
Atherosclerosis, Cardiovascular Disease
A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men
This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
- Trial name
- NCT00549653
- Testing
- GW856553
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-alcoholic Steatohepatitis
A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by…
- Trial name
- NCT04722653
- Testing
- NNC0194-0499
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401
The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy…
- Trial name
- NCT01627002
- Testing
- PA401
- Where
- United Kingdom
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- ProtAffin Biotechnologie AG
Nasal Decolonization of Staphylococcus Aureus
Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus Aureus
A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically to the anterior nares in subjects with…
- Trial name
- NCT05889351
- Testing
- Vehicle gel, 4 + 4 applications or 4 + 2 applications, LTX-109 3% gel, 4 + 4 applications, LTX-109 3% gel, 4 + 2 applications
- Where
- Sweden
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pharma Holdings AS
Healthy
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel
- Trial name
- NCT03098953
- Testing
- Loteprednol Etabonate
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Healthy
Clinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Administration of ZE50-0134 at 5 Dose Levels in Healthy Volunteers
A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE50-0134 administered orally in healthy volunteers.
- Trial name
- NCT06787131
- Testing
- Rabeprazole 20 mg, Itraconazole (200 mg)
- Where
- Australia
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Lomond Therapeutics Holdings, Inc.
Endometriosis
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670
In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects.
- Trial name
- NCT02202408
- Testing
- SKI2670
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Obesity
A Study of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Participants and a Study of JNJ-6456511 in Otherwise Healthy Obese Adult Participants After Multiple Dose
The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC administrations in the thigh versus the abdomen in…
- Trial name
- NCT03586843
- Testing
- JNJ-64565111
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Male Volunteers
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses…
- Trial name
- NCT03468725
- Testing
- XPF-008, Microcrystalline Cellulose
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
Chronic Obstructive Pulmonary Disease
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)
Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).
- Trial name
- NCT06944925
- Testing
- BBT002
- Where
- 14 sites in United States, Australia and 3 more
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- Bambusa Therapeutics
Amyotrophic Lateral Sclerosis
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis
Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts…
- Trial name
- ALS (NCT07221240)
- Testing
- Amisodin
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- PRG Science & Technology Co., Ltd.
Healthy Volunteers
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy…
- Trial name
- NCT00812825
- Testing
- PF-04171327, Prednisolone, PF-04171327 Tablet
- Where
- Belgium
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Pfizer
Smallpox
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
- Trial name
- NCT00053508
- Testing
- ACAM1000, vaccinia virus (calf lymph) smallpox vaccine: Dryvax
- Where
- 3 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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