Clinical trials: Evaluate the Safety and Tolerability
Drug Drug Interaction
Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.
- Trial name
- NCT05304845
- Testing
- DWP14012, Aspirin
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Advanced Solid Tumors
First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and to determine the maximum tolerable dose (MTD) and/or recommended phase 2 dose (RP2D) of HH30134 administered orally on a continuous…
- Trial name
- NCT04746612
- Testing
- HH30134
- Where
- 4 sites in Australia, China
- Volunteers
- 22 people
- Sponsor
- Haihe Biopharma Co., Ltd.
H1N1 Influenza Virus, Invasive Solid Tumors
Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors
This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of…
- Trial name
- NCT01031719
- Testing
- adjuvanted A(H1N1) influenza vaccine, non-adjuvanted A(H1N1) influenza vaccine
- Where
- 3 sites in Brazil
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Chiltern Pesquisa Clinica Ltda
Pain, Inflammatory
A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA)
This study is the first administration of GSK3858279 in humans and will be conducted in two parts: Part A will consist of a single ascending dose escalation design to evaluate safety, tolerability, PK, TE and immunogenicity of…
- Trial name
- NCT03485365
- Testing
- GSK3858279 IV, GSK3858279 SC
- Where
- 5 sites in Germany, Poland and 1 more
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A SAD, MAD and Food Effect Study to Evaluate the Safety, Tolerability, PK, and PD of AJA001 in Healthy Subjects
This is a Phase 1, double-blind, randomized, placebo- controlled, SAD and MAD study to assess safety, tolerability, PK, and PD of AJA001 in fasted healthy participants.
- Trial name
- NCT06019065
- Testing
- AJA001
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AJNA Australia Pty Ltd
Systemic Lupus Erythematosus
Single Ascending Dose Study of AMG 570 in Healthy Subjects
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single…
- Trial name
- NCT02618967
- Testing
- AMG 570
- Where
- 3 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Amgen
Impaired Glucose Tolerance
Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance
LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance
- Trial name
- LIM (NCT01093677)
- Testing
- LIM-0705
- Volunteers
- 30 people
- Sponsor
- Limerick BioPharma
Bacterial Infection
Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107)…
- Trial name
- NCT05645757
- Testing
- Ertapenem, WCK 6777, Zidebactam
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects
BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria.
- Trial name
- NCT07500181
- Where
- Netherlands
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Asthma
Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with…
- Trial name
- NCT01793298
- Testing
- ASM-024
- Where
- 2 sites in Canada
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Asmacure Ltée
Healthy
A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.
The purpose of this clinical trial is to learn about the pharmacokinetics, safety and tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants.
- Trial name
- NCT05554237
- Testing
- PF-07612577, PF-06264006
- Where
- Belgium
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer
Thyroid Eye Disease
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.
- Trial name
- NCT06248619
- Testing
- Teprotumumab
- Where
- 38 sites in United States, Argentina and 9 more
- Volunteers
- 89 people
- Sponsor
- Amgen
Atopic Dermatitis
HL-300 Ointment in Healthy Volunteers
To evaluate the safety and tolerability of HL-300 ointment following single and multiple topical administrations in healthy Chinese adult volunteers.
- Trial name
- NCT07684937
- Testing
- HL-300
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Gastrointestinal Tumor, Solid Tumor
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
This study is an open, multicenter, dose-escalation and expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for…
- Trial name
- NCT06954077
- Testing
- BL-M09D1
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Wet Age Related Macular Degeneration
Clinical Study for the Evaluation of Safety and Tolerability of SCAI-005 Eye Drops
To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers
- Trial name
- NCT06969001
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- SCAI Therapeutics
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
The first-in-human Phase 1/Phase 2a study described herein will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in both healthy participants (HP) and in patients with paroxysmal…
- Trial name
- PNH (NCT05876312)
- Testing
- ADX-038
- Where
- 4 sites in Australia, United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- ADARx Pharmaceuticals, Inc.
Rheumatoid Arthritis
Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
This Phase 1b/2a study will evaluate safety, tolerability pharmacokinetics (PK) and pharmacodynamics (PD) of brodalumab when administered in multiple subcutaneous (SC) and intravenous (IV) doses in patients with active rheumatoid…
- Trial name
- NCT00771030
- Testing
- Brodalumab
- Volunteers
- 40 people
- Sponsor
- Amgen
Obesity
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.
- Trial name
- NCT03757130
- Testing
- AMG 598, Liraglutide
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Amgen
Pneumococcal Infections
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of…
- Trial name
- NCT03565900
- Testing
- V114, Prevnar 13™, PNEUMOVAX™23
- Where
- 52 sites in United States, Australia and 8 more
- Volunteers
- 277 people
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus (RSV)
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to <18 years of age at high risk for RSV disease, including those who are immunocompromised.
- Trial name
- NCT07839871
- Testing
- RSVpreF
- Where
- 20 sites in United States, Japan and 2 more
- Volunteers
- 920 people, healthy volunteers welcome
- Sponsor
- Pfizer
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