Clinical trials: Safety and Tolerability in Healthy Subjects
Influenza
Phase 1b Influenza Vaccine Study in Healthy Subjects
The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects.
- Trial name
- NCT01181336
- Testing
- Influenza vaccine (FLU-v), FLU-v Control
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- PepTcell Limited
Healthy
The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects
A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects
- Trial name
- NCT05032144
- Testing
- STSA-1002 injection
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Healthy
Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects
This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051.
- Trial name
- NCT00409500
- Testing
- AQW051
- Where
- Japan
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis
Management of Moderate to Severe Pain
Pharmacokinetics Study of ALO-02 and OxyContin
To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers
- Trial name
- NCT01557257
- Testing
- ALO-02, Naltrexone block, OxyContin
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
Chronic Obstructive Pulmonary Disease (COPD)
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential.
- Trial name
- NCT01754844
- Testing
- AZD7624
- Where
- United Kingdom
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
To Investigate Safety, Tolerability and Pharmacokinetics of TC-5214 in Healthy Male Japanese Subjects
The purpose of this study is to assess safety, tolerability and pharmacokinetics after a single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.
- Trial name
- NCT01175564
- Testing
- TC-5214
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infections, Bacterial
Single Dose Escalation First Time in Human PK Study
This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects
- Trial name
- NCT00828867
- Testing
- 100 mg GSK investigational drug, 200 mg GSK investigational drug, 400 mg GSK investigational drug
- Where
- Australia
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pharmacokinetics
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.
- Trial name
- NCT03629067
- Testing
- Treatment T, Treatment R
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Tuberculosis, Tuberculosis, Pulmonary
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
- Trial name
- NCT04865536
- Testing
- TBI-223 1800 mg, TBI-223 2400mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Staphylococcus Aureus Bloodstream Infection
A Phase I Study of XJ101 in Chinese Healthy Subjects
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria.
- Trial name
- NCT06014736
- Testing
- XJ101 for Injection
- Where
- China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Starmab biologics（Shanghai）Co,.ltd
Chronic Kidney Disease
A Study to Assess the Safety and Pharmacokinetics of Verinurad and Allopurinol in Asian and Chinese Subjects
This is a randomized, placebo controlled, double-blind study with two separate cohorts to assess safety, tolerability and pharmacokinetics of verinurad and allopurinol in healthy subjects.
- Trial name
- NCT03836599
- Testing
- Verinurad, Allopurinol
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Combined Single and Multiple Ascending Dose Study of ASP6858 in Healthy Subjects
The purpose of this study is evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the…
- Trial name
- NCT02359032
- Testing
- ASP6858
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Bacterial Infections
A Single Dose Study of Debio 1450 in Healthy Subjects
The sponsor is trying to develop a medicine for infections that are not cured by regular antibiotics. They have an experimental drug called Debio 1450 that may work. They need about 48 healthy adults to volunteer for this study.
- Trial name
- NCT02162199
- Testing
- Debio 1450
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Healthy Subjects
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.
- Trial name
- NCT05483998
- Testing
- TLC-2716
- Where
- New Zealand
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- OrsoBio, Inc
Heart Failure
A Clinical Study of HRS-7156 in Healthy Participants
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
- Trial name
- NCT07601087
- Testing
- HRS-7156
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Asthma, Chronic Obstructive Pulmonary Disease
PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians
The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in…
- Trial name
- NCT03859414
- Testing
- Therapeutic Dose 1, Therapeutic Dose 2, Supra-therapeutic Dose
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan
A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component…
- Trial name
- NCT02088008
- Testing
- cinidipine, valsartan
- Where
- South Korea
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
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