Clinical trials: Tolerability
Community-acquired Infection
A Study to Evaluate Single and Repeat Doses of IV GSK2251052 in Healthy Male Japanese and Caucasian Subjects and Repeat Doses of Supratherapeutic Doses of IV GSK2251052 in Healthy Volunteers
This is a two-part study. Part A is a three-period study in approximately 24 healthy male Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to investigate the safety, tolerability, and…
- Trial name
- NCT01495065
- Testing
- GSK2251052 750 mg, GSK2251052 1500 mg, GSK2251052 1500 mg BID
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Distress Syndrome in Premature Infant
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
- Trial name
- NCT03969992
- Testing
- AeroFact, nCPAP
- Where
- 41 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Aerogen Pharma Limited
Crohn's Disease
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently…
- Trial name
- NCT00055536
- Testing
- natalizumab
- Where
- 18 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biogen
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.
- Trial name
- ENLIVEN (NCT04929483)
- Testing
- BIO89-100
- Where
- 89 sites in United States, Puerto Rico
- Volunteers
- 222 people
- Sponsor
- 89bio, Inc.
Solid Tumor, Lymphoma
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
- Trial name
- NCT05357651
- Testing
- LB1410
- Where
- China
- Volunteers
- 100 people
- Sponsor
- L & L Bio Co., Ltd., Ningbo, China
Knee Osteoarthritis
Phase Ib Trial of Injectable RAB001 for Knee Osteoarthritis
This is a randomized, double-blind, placebo-controlled dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of intra-articular injection of RAB001 in participants…
- Trial name
- LBRC_RAB001_OA (NCT07652372)
- Testing
- RAB001 medium dose
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
Immune System Disorder
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection…
- Trial name
- NCT03357939
- Testing
- HLX03, adalimumab
- Where
- China
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Advanced Solid Tumor
A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive advanced solid tumors.
- Trial name
- NCT04941339
- Testing
- MRG002
- Where
- China
- Volunteers
- 74 people
- Sponsor
- Shanghai Miracogen Inc.
Vaccines, Pneumococcal
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy 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
- NCT00474539
- Testing
- 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine
- Where
- 27 sites in Spain
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bowel Preparation for Colonoscopy
Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing
Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy.
- Trial name
- NCT06728839
- Testing
- 1L PEG + 50g magnesium sulfate, 3L PEG, 4L PEG
- Volunteers
- 1,329 people, healthy volunteers welcome
- Sponsor
- Changhai Hospital
Onychomycosis
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the…
- Trial name
- NCT02547701
- Testing
- P-3058
- Where
- 5 sites in Belgium, Germany and 3 more
- Volunteers
- 20 people
- Sponsor
- Polichem S.A.
Type 2 Diabetes Mellitus
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.
- Trial name
- NCT01242228
- Testing
- ipragliflozin, DPP-4 inhibitor
- Where
- 6 sites in Japan
- Volunteers
- 106 people
- Sponsor
- Astellas Pharma Inc
HIV Infections
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects
The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg…
- Trial name
- NCT00146328
- Testing
- Tipranavir
- Where
- 233 sites in United States, Argentina and 16 more
- Volunteers
- 997 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
To assess pharmacokinetics, safety, and tolerability of multiple oral doses of verducatib in healthy Chinese male and female trial participants in order to facilitate the clinical development of verducatib in China.
- Trial name
- NCT07531628
- Testing
- Verducatib
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Solid Malignancies
Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies
The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetics (PK), safety/ tolerability and preliminary efficacy of OB318 in patients with advanced solid malignancies.
- Trial name
- NCT02347228
- Testing
- OB318 capsule
- Where
- 2 sites in Taiwan
- Volunteers
- 21 people
- Sponsor
- Oneness Biotech Co., Ltd.
Oral Mucositis
Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head…
- Trial name
- NCT03234465
- Testing
- AG013
- Where
- 50 sites in United States, Belgium and 2 more
- Volunteers
- 200 people
- Sponsor
- Oragenics, Inc.
Healthy Volunteers, Moderate to Severe Alzheimer Patients
A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease
This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201.
- Trial name
- NCT01513967
- Testing
- RPh201, botanical drug product
- Where
- 2 sites in Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Regenera Pharma Ltd
NASH - Nonalcoholic Steatohepatitis
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Trial name
- HM-TRIA-201 (NCT04505436)
- Testing
- HM15211
- Where
- 60 sites in United States, South Korea
- Volunteers
- 215 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Diabetes Mellitus, Type 1
Safety of ENC-201-CED ENCRT
The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.
- Trial name
- NCT06408311
- Testing
- ENC-201-CED hPI
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Encellin