Clinical trials: Safety and Pharmacokinetics
Healthy
A Study of LY3463251 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
- Trial name
- NCT03764774
- Testing
- LY3463251
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884
A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers
- Trial name
- NCT03001297
- Testing
- MEDI5884 Dose 1, MEDI5884 Dose 2, MEDI5884 Dose 3
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Overweight and Obesity
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
- Trial name
- DA168 (NCT06534320)
- Testing
- DA-302168S
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Healthy
First-in-Human Single and Multiple Dose of GLPG1972
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo.
- Trial name
- NCT02612246
- Testing
- GLPG1972 single ascending doses, GLPG1972 multiple ascending doses
- Where
- Belgium
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Healthy
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers
- Trial name
- NCT04159961
- Testing
- DWJ211
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Malaria
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz
This study assessed the effect of multiple doses of a moderate inducer of cytochrome P450 (CYP) 3A4 (efavirenz) on the pharmacokinetics (PK) of ganaplacide and lumefantrine combination.
- Trial name
- NCT05330273
- Testing
- Ganaplacide, Lumefantrine, Efavirenz
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diabetes, Diabetes Mellitus, Type 2
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01690169
- Testing
- NNC0113-0987
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers
The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.
- Trial name
- NCT02333318
- Testing
- VVZ-149 injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vivozon, Inc.
Healthy
A First in Human Trial Evaluating THB335 in Healthy Participants
This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part…
- Trial name
- NCT06425861
- Testing
- THB335 single dose, THB335 fasted/fed, THB335 multiple dose
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Third Harmonic Bio, Inc.
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Healthy
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed…
- Trial name
- NCT03247673
- Testing
- CT-P16, EU-approved Avastin, US-licensed Avastin
- Where
- 3 sites in South Korea
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects
Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.
- Trial name
- NCT02777008
- Testing
- CTP-543
- Where
- Australia
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Healthy
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses…
- Trial name
- NCT06715540
- Testing
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
- Trial name
- NCT06716190
- Testing
- Mid-dose bid BI 3731579, Midazolam, Low-dose bid BI 3731579
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Neoplasm Malignant
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
Primary Objective: To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended…
- Trial name
- NCT03324113
- Testing
- SAR408701, dexamethasone, naphazoline
- Where
- 3 sites in Japan
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Sanofi
Atopic Dermatitis
Evaluation of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD)
This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate…
- Trial name
- NCT05859724
- Testing
- NM26-2198
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Yellow Jersey Therapeutics AG
Healthy
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants
The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral administration.
- Trial name
- NCT02555124
- Testing
- JNJ-42847922, 5 mg, JNJ-42847922, 20 mg, JNJ-42847922, 40 mg
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Dyslipidemias, Familial Hypercholesterolemia
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial…
- Conditions
- Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
- Trial name
- NCT03747224
- Testing
- ARO-ANG3, sterile normal saline (0.9% NaCl)
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Heart Failure
A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy Volunteers
To evaluate the pharmacokinetic properties and safety of "BR1016A" and "BR1016B" in healthy adults.
- Trial name
- NCT05102903
- Testing
- BR1016A, BR1016B
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Healthy Volunteers
A Study of LY4178256 in Healthy Participants
The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants.
- Trial name
- NCT07698210
- Testing
- LY4178256
- Where
- 2 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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