Clinical trials: Double-blind Randomized Controlled Study
Growth
A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have…
- Trial name
- TENUTO (NCT03062761)
- Testing
- Infant Formula with prebiotics, Standard Infant Formula
- Where
- 15 sites in Finland, France and 4 more
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Healthy
Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers
This study consists of Part 1 followed Part 2. Part 1 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and active comparator(Rebamipide) in healthy…
- Trial name
- NCT05303961
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Samjin Pharmaceutical Co., Ltd.
Type 2 Diabetes Mellitus
Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of twelve weeks of KBP-042 administered as daily s.c.
- Trial name
- NCT03230786
- Where
- 30 sites in Czechia, Denmark and 4 more
- Volunteers
- 255 people
- Sponsor
- KeyBioscience AG
T2DM (Type 2 Diabetes Mellitus)
Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
- Trial name
- HARMONY (NCT06415773)
- Testing
- HTD1801, Dapagliflozin
- Where
- 53 sites in China
- Volunteers
- 367 people
- Sponsor
- Shenzhen HighTide Biopharmaceutical Ltd.
Autoimmune Encephalitis (AE)
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE).
- Trial name
- Polaris (NCT07583641)
- Testing
- Efgartigimod PH20 (ARGX-113) SC
- Where
- 2 sites in United States
- Volunteers
- 170 people
- Sponsor
- argenx
Healthy Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
- Trial name
- NCT07222254
- Testing
- AZD0292
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Schizophrenia
A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia
A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States.
- Trial name
- NCT05848700
- Testing
- SEP-363856
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Osteoarthritis of the Knee
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects…
- Trial name
- NCT02067611
- Testing
- X0002
- Where
- 20 sites in United States
- Volunteers
- 216 people
- Sponsor
- Lina Xu
Opioid Dependence
Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- NCT00447564
- Testing
- Probuphine
- Where
- 18 sites in United States
- Volunteers
- 163 people
- Sponsor
- Titan Pharmaceuticals
Autism Spectrum Disorder
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
- Trial name
- Envision (NCT03664232)
- Testing
- JNJ-42165279
- Where
- 9 sites in United States
- Volunteers
- 78 people
- Sponsor
- Janssen Research & Development, LLC
Acute Ischemic Stroke
A Phase 2a Study to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke
This is a trial to evaluate the safety and effect of three intravenous (IV) doses of NTS-521 for the early recovery treatment of acute ischemic stroke (AIS). Participants will be followed for 90 days.
- Trial name
- ACT-IVATE (NCT07742098)
- Testing
- NTS-521
- Volunteers
- 140 people
- Sponsor
- NeuroTrauma Sciences, LLC
Chronic Genotype 1a or 1b HCV Infection
GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects…
- Trial name
- NCT01434498
- Testing
- GS-5885 tablet, GS-9451 tablet, tegobuvir capsule
- Where
- 50 sites in United States, Canada and 1 more
- Volunteers
- 163 people
- Sponsor
- Gilead Sciences
Tobacco Dependence
Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home.
- Trial name
- NCT01296698
- Testing
- Nicotine
- Where
- 19 sites in United States
- Volunteers
- 257 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Healthy Subjects
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
- Trial name
- NCT05503693
- Testing
- AP303 50 μg, AP303 150 μg, AP303 300 μg
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Alebund Pty Ltd
Overweight and Obesity
A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
This is a study of HS-20094 in participants with overweight and obesity. The main purpose is to learn more about how HS-20094 affects body weight.
- Trial name
- NCT06118021
- Testing
- HS-20094
- Where
- 2 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overactive Bladder (OAB)
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
- Trial name
- PILLAR (NCT02216214)
- Testing
- Mirabegron
- Where
- 120 sites in United States, Canada
- Volunteers
- 888 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Schizophrenia
Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute…
- Trial name
- PRISMA-3 (NCT03160521)
- Testing
- Risperidone ISM 75 mg, Risperidone ISM 100 mg
- Where
- 31 sites in United States, Ukraine
- Volunteers
- 438 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Paroxysmal Nocturnal Hemoglobinuria
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults
Primary objective The tolerability and safety of SAR443809 Secondary The PK parameters of SAR443809 The PD activity of SAR443809 The immunogenicity of SAR443809
- Trial name
- NCT06326814
- Testing
- Humanized anti-Factor Bb monoclonal antibody
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Sanofi
Ulcerative Colitis
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated.
- Trial name
- PROREM UC (NCT03415711)
- Testing
- VSL#3®, Mesalamine
- Where
- Italy
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- VSL Pharmaceuticals
Ulcerative Colitis, Crohn Disease
HMPL004-6599 Phase I Dose-escalating Study
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers
- Trial name
- NCT03597971
- Testing
- HMPL004-6599
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nutrition Science Partners Limited
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