Clinical trials: Safety and Tolerability
Non-Small Cell Lung Cancer
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the…
- Trial name
- NCT07079475
- Testing
- DZD6008, Sunvozertinib, Osimertinib
- Where
- 14 sites in China
- Volunteers
- 220 people
- Sponsor
- Dizal Pharmaceuticals
Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
- Trial name
- NCT05761301
- Testing
- ALN-KHK
- Where
- 15 sites in United States, Canada
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Opioid Induced Constipation (OIC)
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with…
- Trial name
- NCT00600119
- Testing
- NKTR-118
- Where
- 33 sites in United States
- Volunteers
- 207 people
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus Infections
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.
- Trial name
- NCT02864628
- Testing
- MVA-BN-RSV
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bavarian Nordic
TTR-mediated Amyloidosis
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01617967
- Testing
- Patisiran
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 29 people
- Sponsor
- Alnylam Pharmaceuticals
Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Systemic sclerosis (SSc) is a rare autoimmune disease in which many patients experience Raynaud's phenomenon (RP) - painful episodes where commonly fingers or toes change color and become painful, numb, or tingly, usually…
- Trial name
- RE-WARM (NCT07748000)
- Testing
- LIQ861 (treprostinil) inhalation powder - Dose Titration Arm, LIQ861 (treprostinil) inhalation powder - fixed dose arm
- Volunteers
- 75 people
- Sponsor
- Liquidia Technologies, Inc.
Arthroplasty, Replacement, Knee, Knee Injuries
ALGRX 4975 After Total Knee Replacement
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee.
- Trial name
- NCT00132392
- Testing
- ALGRX 4975
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- AlgoRx Pharmaceuticals
Healthy Volunteers
Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses…
- Trial name
- NCT07787611
- Testing
- MWN109 tablet
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
Pulmonary Arterial Hypertension
Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.
- Trial name
- BREEZE (NCT03950739)
- Testing
- Treprostinil Inhalation Powder
- Where
- 16 sites in United States
- Volunteers
- 51 people
- Sponsor
- United Therapeutics
SCLC, NEC
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
- Trial name
- NCT07416695
- Testing
- HLX3901
- Where
- 2 sites in China
- Volunteers
- 138 people
- Sponsor
- Shanghai Henlius Biotech
Highly Sensitized Patients on Waiting List for Kidney Transplantation
Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation.
- Trial name
- NCT04174677
- Testing
- Inebilizumab, VIB4920, Inebilzumab+VIB4920
- Where
- 2 sites in United States
- Sponsor
- Amgen
Pulmonary Fibrosis, Tumor
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
- Trial name
- NCT05740475
- Testing
- 9MW3811 injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Major Depressive Disorder, Recurrent, Unspecified
Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Objectives To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects. To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.
- Trial name
- NCT02271412
- Testing
- LY03005
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
- Trial name
- NCT02970019
- Testing
- K0706
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sun Pharma Advanced Research Company Limited
Rheumatoid Arthritis
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments.
- Trial name
- NCT03139136
- Testing
- MBS2320
- Where
- 3 sites in Georgia, Moldova and 1 more
- Volunteers
- 121 people
- Sponsor
- Modern Biosciences Ltd
Cough
The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects
This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The study is split into two parts. Part A will assess the safety and tolerability of the new drug.
- Trial name
- FTIH (NCT01494636)
- Testing
- GSK2339345 (solution), GSK2339345 (nebulised), Lidocaine
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Type 2 Diabetes Mellitus, Diabetes
Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus
This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2 diabetic subjects.
- Trial name
- NCT02455011
- Testing
- REMD-477
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- REMD Biotherapeutics, Inc.
Osteoarthritis, Knee, Osteoarthritis, Hip
Open Label Safety and Tolerability Study of COV155 in Subjects With Osteoarthritis (OA) or Chronic Low Back Pain (CLBP)
A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or moderate to severe chronic low back pain.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Low Back Pain
- Trial name
- NCT01722864
- Testing
- COV155
- Where
- 34 sites in United States
- Volunteers
- 153 people
- Sponsor
- Mallinckrodt
Rheumatoid Arthritis
An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
- Trial name
- NCT07052032
- Testing
- CND261
- Where
- 2 sites in Moldova, Ukraine
- Volunteers
- 47 people
- Sponsor
- Candid Therapeutics
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