Clinical trials: Food Safety
Healthy Adult Participants
A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11
This is a randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts.
- Trial name
- NCT06707142
- Testing
- TBD11
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Smoking Cessation
A First-in-Human Study of SBP-9330 in Healthy Subjects
This is a single center, first-in-human, randomized, double-blind, placebo-controlled, Single-Ascending Dose (SAD) / Multiple-Ascending Dose (MAD) study incorporating a food-effect cohort.
- Trial name
- NCT04948827
- Testing
- SBP-9330
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Camino Pharma, LLC
Cashew Nut Allergy, Tree Nut Allergies
UNC Cashew Sublingual Immunotherapy
The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT.
- Trial name
- CASCADES (NCT07170540)
- Testing
- Cashew sublingual immunotherapy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV/TB Coinfection
Efficacy, Safety and Pharmacokinetics of DTG With RIF
The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy.
- Trial name
- NCT03731559
- Testing
- DTG 50 mg OD with food, DTG 50 mg BID
- Where
- 10 sites in Thailand
- Volunteers
- 123 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Nonalcoholic Steatohepatitis
First-in-Human Study of SRT-015 in Healthy Subjects.
This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers.
- Trial name
- NCT04887038
- Testing
- SRT-015
- Where
- Australia
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetics(PK), Pharmacodynamics(PD) and Food Effect of HRS9950 in Healthy and CHB Subjects
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS9950.
- Trial name
- NCT04464733
- Testing
- HRS9950
- Where
- China
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hereditary Angioedema
A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers
This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety, tolerability, and pharmacokinetics of KVD824 following administration of single and multiple ascending oral doses; followed by a…
- Trial name
- NCT05178355
- Testing
- KVD824
- Where
- United Kingdom
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Healthy
A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects
The objectives of this study are: Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7…
- Trial name
- NCT02792998
- Testing
- IW-1701
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cyclerion Therapeutics
Rheumatoid Arthritis (RA)
Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in…
- Trial name
- NCT07266207
- Testing
- ARD-885 Tablets
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Artivila (Shenzhen) Innovation Center, Ltd
Chronic Hepatitis B
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091.
- Trial name
- NCT04480294
- Testing
- HRS5091
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Cytomegalovirus Infection
Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once…
- Trial name
- NCT02454699
- Testing
- MBX400
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Inflammatory Bowel Diseases
Phase 1 Study for IPG11406 in Health Volunteer
A phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and food effect of orally administered IPG11406 in healthy adult…
- Trial name
- NCT06255834
- Testing
- IPG11406
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
MASH
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS060304 in Healthy and Elevated LDL-C Subjects.
- Trial name
- NCT06485245
- Testing
- CS060304
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Central Nervous System Diseases
Phase 1 ALKS 1140 in Healthy Adults
To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects
- Trial name
- NCT05019105
- Testing
- ALKS 1140
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.
- Trial name
- NCT04801693
- Testing
- BI 1819479
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Mixed Dyslipidemia
The Food Effect on PK Characteristics and Safety Profiles of PA-111
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
- Trial name
- NCT06976489
- Testing
- PA-111
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Food Effect of KH607 in Chinese Health Participants
A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of KH607 in Healthy Chinese Participants
This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants…
- Trial name
- NCT07634874
- Testing
- KH607
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Rheumatoid Arthritis, Psoriasis
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis
The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly…
- Conditions
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases
- Trial name
- NCT03329885
- Testing
- BMS-986251
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants.
- Trial name
- NCT06213818
- Testing
- INCB160058, Esomeprazole, Famotidine
- Where
- Australia
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Community-acquired Infection
A Four Part Study to Investigate Relative Bioavailability, Safety and Tolerability of up to 5 Oral Formulation of GSK2251052 in Order to Identify a Formulation for Further Evaluation in a Future Later Phase Study
GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with tRNA and is currently in development for the…
- Trial name
- Relative Bio (NCT01702350)
- Testing
- GSK2251052
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline