Clinical trials: Upper Limb
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Healthy
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed…
- Trial name
- NCT03247673
- Testing
- CT-P16, EU-approved Avastin, US-licensed Avastin
- Where
- 3 sites in South Korea
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy Volunteer
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways
In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab…
- Trial name
- NCT06741657
- Testing
- Litifilimab, AI, OBI
- Where
- 2 sites in United States
- Volunteers
- 404 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection
This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics…
- Trial name
- NCT06095427
- Testing
- LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia
- Where
- 2 sites in Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Shandong Boan Biotechnology Co., Ltd
Type 2 Diabetes Mellitus
Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human
This study was designed as a single-center, single-arm, open, fixed-sequence, self-controlled trial in healthy subjects.
- Trial name
- NCT06495931
- Testing
- HRS-1780 tablets, HR20033 tablets, HRS-7535 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.
- Trial name
- NCT04514796
- Testing
- Adalimumab
- Where
- Germany
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Overweight, Obesity
Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.
- Trial name
- NCT07502001
- Testing
- Acetaminophen, Metformin, Warfarin
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Vaccines, Pneumococcal Conjugate Vaccine
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to…
- Trial name
- NCT00500357
- Testing
- 13-valent Pneumococcal Conjugate Vaccine
- Where
- 16 sites in South Africa
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Safety of Short Term Creatine Hydrochloride Dosing
Short-Term Safety of Low-Dose Creatine Hydrochloride: A 28-Day Single-Arm Pilot Study
Background: Creatine monohydrate (typically 5-20 g/day) has a well-established safety profile across diverse populations. Creatine hydrochloride (CR-HCl) is a highly soluble creatine formulation that may allow effective…
- Trial name
- NCT07521059
- Testing
- creatine supplementation
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Vireo Systems, Inc.
Body Fat Disorder
CoolSculpting the Upper Arm Study
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.
- Trial name
- ARM (NCT02669329)
- Testing
- CoolSculpting device with vacuum applicator.
- Where
- 2 sites in Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zeltiq Aesthetics
Drug-Drug Interaction
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
This study will be an open-label, parallel-arm study to determine if a prior intra-articular (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or pharmacokinetics (PK) of a subsequent IA injection of the…
- Trial name
- NCT04598542
- Testing
- Lorecivivint (LOR), Triamcinolone acetonide (TA)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Biosplice Therapeutics, Inc.
Healthy Volunteers
A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GS-4774 (GI-13020) at Various Dose Levels and Regimens in Healthy Adults
This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in various doses and dosing regimens in healthy adults at one center in the US.
- Trial name
- NCT01779505
- Testing
- GS-4774
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hemophilia A
Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in Japanese patients with severe hemophilia A.
- Trial name
- GENEr8-JPN (NCT06224907)
- Testing
- Valoctocogene roxaparvovec
- Where
- 4 sites in Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BioMarin Pharmaceutical
Human Immunodeficiency Virus Infection
A Drug-drug Interaction Study of SHR2150 on Healthy Chinese Volunteers
The study is a single-centre, open-label, fixed-sequence, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects. Subjects will take SHR2150 on Day 1 and Day 21, and take efavirenz from Day 7 to Day 26.
- Trial name
- NCT05141422
- Testing
- SHR2150 tablet、efavirenz
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pneumococcal Disease
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India.
- Trial name
- NCT05329259
- Testing
- 13-valent pneumococcal conjugate vaccine
- Where
- 5 sites in India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
- Trial name
- NCT06741397
- Testing
- CAB LA, New formulation of CAB LA
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
NAD, NAD+ Levels in the Blood
Comparison of Three Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels
This is a double-blind, placebo-controlled, parallel-group study evaluating the effects of three distinct Qualia NAD⁺ formulations on intracellular NAD⁺ levels in healthy adults aged 35-75 years.
- Trial name
- NCT07132801
- Testing
- Qualia NAD⁺ version 1, Qualia NAD⁺ version 2, Qualia NAD⁺ version 3
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Qualia Life Sciences
Asthma
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the…
- Trial name
- NCT01737892
- Testing
- Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Cardiomyopathy, Hypertrophic Obstructive
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic…
- Trial name
- HORIZON-HCM (NCT05414175)
- Testing
- Mavacamten
- Where
- 20 sites in Japan
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy…
- Trial name
- NCT04439929
- Testing
- TUR01, Adalimumab-EU
- Where
- Germany
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Turgut İlaçları A.Ş.