Clinical trials: Healthy Population
Healthy Adult Subjects
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05.
- Trial name
- NCT05632211
- Testing
- AVT05, Simponi
- Where
- 2 sites in New Zealand, United Kingdom
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Pulmonary Disease, Chronic Obstructive
Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects
GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases.
- Trial name
- NCT03189589
- Testing
- GSK2269557 500 µg, GSK2269557 750 µg
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).
- Trial name
- NCT00845663
- Testing
- Certolizumab pegol
- Where
- France
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.
- Trial name
- NCT02932904
- Testing
- Vortioxetine, Paroxetine
- Where
- 15 sites in United States
- Volunteers
- 361 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Subjects
THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC
This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC…
- Trial name
- NCT02625207
- Testing
- Maraviroc (Part 1), Maraviroc (Part 2), Darunavir/cobicistat (Part 2)
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Subjects
A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution
- Trial name
- NCT02756624
- Testing
- AC-170 0.24%, AC-170 Vehicle
- Where
- United States
- Volunteers
- 516 people
- Sponsor
- Nicox Ophthalmics, Inc.
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Schizophrenia, Alzheimer Disease
Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease…
- Trial name
- NCT02392468
- Testing
- BI 409306 25 mg, BI 409306 50 mg
- Where
- 3 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Chikungunya Virus Infection
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
- Trial name
- NCT03483961
- Testing
- CHIKV VLP/unadjuvanted, CHIKV VLP/adjuvanted
- Where
- 3 sites in United States
- Volunteers
- 445 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Asthma, Chronic Obstructive Pulmonary Disease COPD
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men
This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics [PD]) and how the body affects the drug…
- Trial name
- NCT02645253
- Testing
- AZD7594 inhalation powder (200 μg), AZD7594 inhalation powder (400 μg), AZD7594 pressurized inhalation suspension (200 μg)
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Asthma
A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
- Trial name
- NCT05602025
- Testing
- Depemokimab
- Where
- 3 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Renal Insufficiency, Healthy
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
- Trial name
- NCT03302091
- Testing
- BI 1467335
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Meningitis, Meningococcal, Serogroup B
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the…
- Trial name
- NCT02305446
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine
- Where
- Poland
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Novartis
Rheumatoid Arthritis
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects
- Trial name
- NCT01439204
- Testing
- Abatacept (BMS-188667)
- Where
- United States
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the…
- Trial name
- NCT04445090
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure
The main objective of the study is investigate the effect of escalating doses of oral tyramine on systolic blood pressure (SBP) at baseline and following an oral treatment with BI 1467335 up to 39 days at a low or high dose once…
- Trial name
- NCT03979820
- Testing
- BI 1467335, Phenelzine sulfate, Tyramine
- Where
- Netherlands
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects
- Trial name
- NCT03970824
- Testing
- CT-P17, US-licensed Humira, EU-approved Humira
- Where
- 9 sites in South Korea
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Celltrion
Erectile Dysfunction
Study Evaluating the Effects of Avanafil on Semen Parameters
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
- Trial name
- NCT01768676
- Testing
- avanafil
- Where
- 15 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC