Clinical trials: sponsored by Hoffmann-La Roche
Influenza, Human, Respiratory Tract Infections
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in…
- Conditions
- Influenza, Human, Respiratory Tract Infections, Post-exposure Prophylaxis
- Trial name
- Pearlstone (NCT07827599)
- Testing
- Baloxavir marboxil
- Where
- 8 sites in China
- Volunteers
- 325 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD), Healthy Participants
A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
This study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of single and multiple doses of RO7830698 in healthy participants and participants with chronic obstructive…
- Trial name
- NCT07822334
- Testing
- RO7830698
- Where
- United Kingdom
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
- Trial name
- NCT07271693
- Testing
- RO7806881
- Where
- New Zealand
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of pegozafermin administered in the abdomen, thigh, or upper arm in healthy participants.
- Trial name
- NCT07835243
- Testing
- Pegozafermin
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Renal Impairment
A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal…
- Trial name
- NCT07741604
- Testing
- RO7795081
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI)…
- Trial name
- NCT07626515
- Testing
- Enicepatide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081
This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants. Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on…
- Trial name
- NCT06809608
- Testing
- RO7795081, Itraconazole, Gemfibrozil
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Overweight, Obesity
A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants
This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered…
- Trial name
- NCT06982131
- Testing
- RO7795081, Rosuvastatin, Pitavastatin
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Stable Coronary Artery Disease, Healthy Volunteers
A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in…
- Trial name
- NCT07495813
- Testing
- RO7763505
- Where
- Netherlands
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Paroxysmal Hemoglobinuria, Nocturnal
Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria
This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be…
- Trial name
- COMPOSER (NCT03157635)
- Testing
- Crovalimab
- Where
- 15 sites in France, Germany and 5 more
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Overweight or Obesity
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
This is an investigator- and participant-blind, randomized, placebo-controlled, parallel-group, Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of orally administered…
- Trial name
- NCT07499050
- Testing
- RO7795081
- Where
- 2 sites in China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Dry Eye Disease
A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control…
- Trial name
- NCT07025811
- Testing
- Vevye®, Xiidra®
- Where
- 8 sites in United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
A Study Conducted to Evaluate the Conjunctiva and Tenon's Capsule Status of Healthy Subjects and in Participants With Neovascular Age-related Macular Degeneration (nAMD)/Diabetic Macular Edema (DME)
The purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (SD-OCT) in participants with nAMD/DME and age-matched healthy subjects.
- Trial name
- NCT06723288
- Where
- 20 sites in Spain
- Volunteers
- 736 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics…
- Trial name
- NCT05763576
- Testing
- RO7565020, Nucleos(t)ide analogue (NUC) treatment
- Where
- 9 sites in United States, Hong Kong and 5 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.
- Trial name
- NCT01620931
- Testing
- RO5469754
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants
This study will investigate how RO7269162 labeled with a carbon tracer ([14C]) is absorbed, metabolized, and eliminated by the body after a single dose in healthy male volunteers.
- Trial name
- NCT06733298
- Testing
- [ 14C]-labeled RO7269162
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Male Participants
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
This is a Phase I, open-label, non-randomized, parallel-group, single-dose study in healthy adult male participants. The aim is to investigate the relative bioavailability (rBA) of NXT007 among subcutaneous (SC) injection sites…
- Trial name
- NCT06189508
- Testing
- NXT007
- Where
- 2 sites in New Zealand
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety…
- Trial name
- NCT02952924
- Testing
- Midazolam, RO7049389
- Where
- 21 sites in Australia, Bulgaria and 6 more
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Male Subjects
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and…
- Trial name
- NCT05275010
- Testing
- Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, On-Body Delivery System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche