Clinical trials: Safety and Tolerability
Healthy Volunteers, Safety
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose or multiple doses of RCS-21 and their health status will be constantly…
- Conditions
- Healthy Volunteers, Safety, Tolerability, Pharmacokinetics
- Trial name
- AMIR-21 (NCT06752122)
- Testing
- RCS-21 (SAD), RCS-21 (MD)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- RNATICS GmbH
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of IgG Binding Protein LT
This study evaluates the safety and tolerability of the food ingredient IgG Binding Protein LT (BP-LT) when added to a daily diet.
- Trial name
- NCT07824011
- Testing
- IgG Binding Protein LT
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Safety, Tolerability
A First-in-Human SAD and MAD Study in HV to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B07) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel…
- Conditions
- Safety, Tolerability, Pharmacokinetic
- Trial name
- NCT07878481
- Testing
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Safety, Tolerability
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.
- Conditions
- Safety, Tolerability, Efficacy
- Trial name
- NCT06639256
- Testing
- Test Product HY07121
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of BP-LT
This study evaluates the safety and tolerability of the food ingredient BP-LT when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption.
- Trial name
- NCT07819695
- Testing
- BP-LT
- Where
- Bangladesh
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Safety and Tolerability in Healthy Volunteers
Safety and User Experience of BP-CBB
This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer…
- Trial name
- NCT07628608
- Testing
- BP-CBB
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women
A Phase II Trial to Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS in HIV- Negative Women
A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women
- Trial name
- CAPRISA 012C (NCT07810062)
- Testing
- Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS
- Where
- Zambia
- Volunteers
- 990 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Healthy, Safety Evaluation of Escalating Doses
A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults
The goal of this clinical trial is to determine the safety, tolerability and effects of Nezavist in healthy adults. The main questions it aims to answer are: What is the safety and maximum tolerated dose (MTD) of orally…
- Conditions
- Healthy, Safety Evaluation of Escalating Doses, Tolerability
- Trial name
- NCT06633562
- Testing
- Nezavist SDD
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Lohocla Research Corporation
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
A Randomized, Open-Label, Evaluator-Blinded, Cross-Over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
- Trial name
- NCT07807891
- Testing
- Tampon
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Lyv Life Inc. (dba: Cora)
Feasibility, Safety and Tolerability of Device
A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier
The goal of this interventional feasibility study is to learn about the feasibility, acceptability, and safety of a novel myofunctional pacifier in infants from birth to 6 months of age.
- Trial name
- NCT07793058
- Testing
- BREATHE myofunctional pacifier
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Keystone OrthotropiX
Safety, Tolerability
Phase 1/2 Clinical Study of HY07121 for Injection (Subcutaneous) in Patients With Advanced Solid Tumors
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 for Injection (Subcutaneous) in participants with advanced solid…
- Conditions
- Safety, Tolerability, Efficacy
- Trial name
- NCT07789327
- Testing
- Test Product HY07121 for Injection (Subcutaneous)
- Volunteers
- 254 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005
Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
- Trial name
- NCT04220073
- Testing
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Safety and Tolerability in Healthy Volunteers
Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
- Trial name
- TRT-448-101 (NCT07745751)
- Testing
- TRT-448
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Trotana, Inc.
Safety, Tolerability
A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel…
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Trial name
- NCT07285967
- Testing
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Safety Issues, Tolerability
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single…
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics
- Trial name
- NCT05142592
- Testing
- IPG7236
- Where
- 7 sites in United States, China
- Volunteers
- 34 people
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Safety, Tolerability
Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study
The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain…
- Trial name
- NCT07660107
- Testing
- Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Kioga Inc.
Pharmacokinetics, Cardiodynamic ECG
A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized trial designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate.
- Conditions
- Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD
- Trial name
- NCT05469854
- Testing
- Linaprazan glurate
- Where
- Sweden
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Safety and Tolerability in Healthy Subjects
Phase 1 Study of Oral MG001
This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some…
- Trial name
- NCT07204171
- Testing
- mitragynine
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZKLJ02 Injection in Healthy Chinese Research Participants
A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous administration of ZKLJ02 injection in…
- Trial name
- ZKLJ02-I (NCT07638098)
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Yunnan Zhongke Longjin Biotechnology Co.,Ltd.