Clinical trials: Dose-escalation
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
SARS-CoV, SARS-CoV-2
Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States
The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults.
- Trial name
- NCT05870839
- Testing
- VXCO-100
- Where
- 3 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company
Healthy Participants, IBD (Inflammatory Bowel Disease)
A Phase I Study of HW201877 in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single…
- Trial name
- NCT07373457
- Testing
- HW201877 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Basic Science: Safety, Tolerability, Efficacy of CLP
Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
- Trial name
- NCT01944007
- Testing
- Cross-Linked Polyelectrolyte (CLP)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sorbent Therapeutics
Malaria
Trial to Evaluate the Safety and Immunogenicity of a Placental Malaria Vaccine Candidate (PRIMVAC ) in Healthy Adults
The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered…
- Trial name
- PRIMALVAC (NCT02658253)
- Testing
- PRIMVAC, GLA-SE, Alhydrogel
- Where
- 2 sites in Burkina Faso, France
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal…
- Trial name
- NCT03482453
- Testing
- TAK-788
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Pulmonary Arterial Hypertension
Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult…
- Trial name
- NCT04903730
- Testing
- AER-901 Solution for Nebulization
- Where
- Australia
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Aerami Therapeutics
Safety
Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in: single dose escalation study of increasing doses of MRX-4…
- Trial name
- NCT03033342
- Testing
- Oral single doses of MRX-4, Oral multiple doses of MRX-4, MRX-4 co-administered with omeprazole
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- MicuRx
Dyslipidemias
Safety, PK, and PD of BSA204 in Chinese Adults With Borderline Elevated Lipoprotein(a)
The purpose of this Phase 1 clinical study is to evaluate the safety and tolerability of a single dose of BSA204 injection in Chinese adults with borderline high levels of lipoprotein(a) [Lp(a)].
- Trial name
- NCT07551505
- Testing
- BSA204
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bisirna Therapeutics (Suzhou) Co., Ltd.
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Gout, Hyperuricemia
Safety and Efficacy Study of Intravenous Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.
- Trial name
- NCT01021241
- Testing
- Uricase-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- EnzymeRx
Lassa Virus Infection
A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001)
This is a randomized, placebo-controlled, single-center, dose finding phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and an observer-blinded treatment phase.
- Trial name
- NCT04055454
- Testing
- MV-LASV
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Themis Bioscience GmbH
Stroke
The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers
Double blind, randomized, placebo control, multiple dose, dose escalation study
- Trial name
- NCT02396069
- Testing
- JPI-289
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
Obesity, Overweight
A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses
This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation…
- Trial name
- NCT07280936
- Testing
- SHR-2906 Injection
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
Healthy
Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of HS-10360 in Healthy Subjects.
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10360 in healthy subjects.
- Trial name
- NCT04986436
- Testing
- HS-10360
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Rheumatic Diseases
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.
- Trial name
- NCT02291471
- Testing
- T0001，10mg, T0001，20mg, T0001，35mg
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Hepatitis B
Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection
The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous injection.
- Trial name
- NCT01606163
- Testing
- GC1102, JW normal saline
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
MELAS Syndrome, Mitochondrial Respiratory Chain Deficiencies
Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers
The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
- Trial name
- NCT03056209
- Testing
- KL1333 25 mg, KL1333 50 mg, KL1333 100 mg
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Yungjin Pharm. Co., Ltd.
Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Prosthetic Joints Infection (PJI)
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.
- Trial name
- NCT06394518
- Testing
- TNP-2092 for injection
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics Inc.
Diabetes
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
- Trial name
- NCT06548815
- Testing
- GZR4
- Where
- China
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Gan and Lee Pharmaceuticals, USA
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