Clinical trials: Tolerability
Metabolic Dysfunction-Associated Steatohepatitis
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, D and F and in participants with a…
- Trial name
- NCT05945537
- Testing
- INI-822 (A)
- Where
- 11 sites in Australia
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Inipharm Australia Pty Ltd
Malaria Falciparum, Malaria Infection
Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso
This is a first-in-humans randomized, double-blind, placebo-controlled, age de-escalation Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine…
- Trial name
- NCT06652737
- Testing
- PfSPZ-LARC2 Vaccine
- Where
- Burkina Faso
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Autoimmune Diseases
A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)
This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).
- Trial name
- NCT05418101
- Testing
- VIS171
- Where
- 10 sites in Bulgaria, Germany and 3 more
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Subjects
A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts).
- Trial name
- NCT03230383
- Testing
- PF-06865571
- Where
- 2 sites in United States, Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Elderly
MAD Study of NX210c
This study will investigate the safety and tolerability of multiple intravenous infusions of NX210c with two ascending doses as well as NX210c pharmacokinetics (PK), and pharmacodynamics (PD) effects in healthy elderly subjects.
- Trial name
- CHDR2235 (NCT05827653)
- Testing
- NX210c
- Where
- Netherlands
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Axoltis Pharma
Covid19
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19
APN01 is a soluble recombinant form of the human angiotensin-converting enzyme 2 (rhACE2) that is currently under development as a therapy for corona-virus-disease 2019 (COVID-19).
- Trial name
- NCT05065645
- Testing
- Angiotensin Converting Enzyme 2, Sodium chloride
- Where
- Austria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Apeiron Biologics
Healthy Volunteers
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers
The purpose of this study is to assess the safety and tolerability of single and multiple intravenous doses of SPR741 when administered to healthy adult volunteers.
- Trial name
- NCT03022175
- Testing
- SPR741
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- NCT07546760
- Testing
- AZD6234, AZD9550
- Where
- 4 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part…
- Trial name
- NCT06350279
- Testing
- HSK39297
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy Volunteers
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).
- Trial name
- NCT02703051
- Testing
- GMI-1271, Filgrastim
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- GlycoMimetics Incorporated
Part I (SAD) - Healthy Participants, Part II (MAD) - Chronic Obstructive Pulmonary Disease
Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants
This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506.
- Conditions
- Part I (SAD) - Healthy Participants, Part II (MAD) - Chronic Obstructive Pulmonary Disease, Part III (J-SD) - Healthy Japanese Participants
- Trial name
- NCT03096795
- Testing
- MEDI3506
- Where
- 2 sites in United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Healthy Volunteers
A Study of Lispro Formulations in Healthy Participants
The purposes of this study are to determine: Part A How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
- Trial name
- NCT02293551
- Testing
- Lispro
- Where
- Singapore
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Chronic Kidney Disease
Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers
This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.
- Trial name
- NCT04734275
- Testing
- AZD5718
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants
This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers.
- Trial name
- NCT04464239
- Testing
- TS-142
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical R&D Inc.
Healthy
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges in Healthy Male Volunteers
The main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days
- Trial name
- NCT02194283
- Testing
- Ambroxol - in single rising doses
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Healthy Male Volunteers
Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
- Trial name
- NCT03532854
- Testing
- Valsartan, Ezetimibe/Rosuvastatin
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific…
- Trial name
- NCT03103451
- Testing
- BCD-121
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are Tolerated
The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy Japanese male subjects following oral administration of multiple rising doses over 14 days.
- Trial name
- NCT03608072
- Testing
- BI 690517
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Melasma
Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma
This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.
- Trial name
- NCT06278948
- Testing
- Group TP, Group CYS
- Where
- India
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cosmetique Active International
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