Clinical trials: Dose-escalation
Healthy Volunteer, Urea Cycle Disorder
Safety and Tolerability of SYNB1020-CP-001
A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics
- Trial name
- SYNB1020CP001 (NCT03179878)
- Testing
- SYNB1020
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Synlogic
Healthy
A Study of LY2541546 in Healthy Postmenopausal Women
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
- Trial name
- NCT01742078
- Testing
- LY2541546 - IV, LY2541546 - SC
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Subjects
Safety and Pharmacokinetics Study of Single Ascending Doses of VV116 in Healthy Volunteers
The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8 subjects in each other group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and PK…
- Trial name
- NCT05227768
- Testing
- VV116 25mg Group, VV116 200mg Group, VV116 400mg Group
- Where
- China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
HIV-1-infection
10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults
Many HIV-infected individuals mount a broad neutralizing serologic response 2-3 years after infection. Broadly neutralizing antibodies might play an important role in protection from acquisition of HIV infection because they can…
- Trial name
- NCT03875209
- Testing
- 10E8.4/iMab
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- David Ho
Fungal Infection
Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects
First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects.
- Trial name
- NCT02956499
- Testing
- APX001 single dose 1, APX001 single dose 2, APX001 single dose 3
- Where
- 2 sites in Netherlands
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Dyslipidemia
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519.
- Trial name
- CKD-519 FIH (NCT02156544)
- Testing
- CKD-519
- Where
- South Korea
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy…
- Trial name
- NCT04555850
- Testing
- Recombinant Human Thymosin β4
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Bacterial Infections
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of…
- Trial name
- NCT05226923
- Testing
- KSP-1007, Meropenem
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Sumitovant Biopharma, Inc.
Healthy Adults
Dose Escalation Trial of CD40.HIVRI.Env Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Volunteers
FIRST PART: DOSE ESCALATION Multicenter double-blind placebo controlled phase I dose-escalation trial that will be conducted in France and Switzerland to evaluate different dose levels of CD40.HIVRI.Env (adjuvanted with Hiltonol)…
- Trial name
- NCT04842682
- Testing
- Solo 0.3 group, Solo 1 group, Solo 3 group
- Where
- 3 sites in France, Switzerland
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Sepsis
A Study of HY209 in Healthy Male Volunteers for Sepsis
A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers
- Trial name
- NCT04255979
- Testing
- HY209
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shaperon
Healthy
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600.
- Trial name
- NCT02309827
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Pfizer
Influenza Prevention, Seasonal Influenza
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better.
- Trial name
- NCT06863142
- Testing
- VRC-FLUMOS0116-00-VP, ALFQ
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Participants
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy Volunteers
To evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, including Factor XI activity and antigen levels, activated partial thromboplastin time, prothrombin time and international normalized ratio of…
- Trial name
- NCT03582462
- Testing
- IONIS FXI-LRx
- Where
- Canada
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Tetanus
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus…
- Trial name
- NCT07149454
- Testing
- Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Human Tetanus Immunoglobulin
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
Healthy Volunteers
A Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers
This is a single-centre, blinded, randomized, placebo controlled, dose escalation study. Up to 9 healthy male volunteers will participate in the study.
- Trial name
- NCT04240223
- Testing
- Brilacidin, 4Mq 99mTc-DTPA
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Innovation Pharmaceuticals, Inc.
Healthy Subjects, Heme Oxygenase
Effects of Heme Arginate in Healthy Male Subjects
Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region).
- Conditions
- Healthy Subjects, Heme Oxygenase, Genetic Polymorphism
- Trial name
- HEMAHS (NCT00682370)
- Testing
- saline solution, heme arginate
- Where
- Austria
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Daniel Doberer
Chronic Weight Management
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
- Trial name
- NCT06427590
- Testing
- ASC47
- Where
- Australia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults
This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.
- Trial name
- NCT03699241
- Testing
- BG505 SOSIP.664 gp140, adjuvanted
- Where
- 3 sites in United States, Kenya
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Systemic Lupus Erythematosus
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in…
- Trial name
- NCT02306629
- Testing
- Epratuzumab sc, Epratuzumab iv
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
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