Healthy Adults Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Denosumab Injection Administered Subcutaneously to Healthy Adults in China
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose
escalation Phase I study in healthy adults in China, conducted in one center.
The objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics
and immunogenicity of denosumab injection (code name:LY06006).
Subjects would be sequentially enrolled in one of three cohorts. Eight subjects in the first
cohort would receive a single 18 mg subcutaneous injection of LY06006. If the safety and
tolerability were confirmed at Day 56, the other 16 subjects would be enrolled in the second
cohort to receive a single 60 mg subcutaneous injection of LY06006. If the safety and
tolerability were confirmed at Day 56 in 60-mg group, the last 8 subjects would be enrolled
in the third cohort to receive a single 120 mg subcutaneous injection of LY06006.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04677920 -
The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology
|
N/A | |
| Active, not recruiting |
NCT03312920 -
Investigating Memory Retrieval Improvement in Healthy Subjects
|
N/A | |
| Completed |
NCT03309072 -
Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task
|
N/A | |
| Completed |
NCT03289832 -
Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin
|
N/A | |
| Enrolling by invitation |
NCT06133530 -
Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica
|
N/A | |
| Completed |
NCT05141903 -
Dietary Supplement With and Without a Probiotic and/or Antibiotic
|
||
| Completed |
NCT01689259 -
Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01187875 -
Resistant Starch and Satiety
|
Phase 0 | |
| Completed |
NCT03312699 -
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
|
Phase 1 | |
| Completed |
NCT03319134 -
Investigating the Neural Correlates in Memory Retrieval After HD-tDCS
|
N/A | |
| Recruiting |
NCT04104360 -
Galacto-oligosaccharides and Intestinal Activity
|
N/A | |
| Completed |
NCT03228693 -
Gene Expression and Biomarker Profiling of Keloid Skin
|
N/A | |
| Completed |
NCT04206293 -
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
|
N/A | |
| Completed |
NCT04146532 -
Aspirin Effects on Emotional Reactions
|
Early Phase 1 | |
| Recruiting |
NCT06011018 -
Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
|
N/A | |
| Completed |
NCT05093205 -
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
|
Phase 1 | |
| Completed |
NCT04596709 -
Investigation of Blood Glucose and Insulin Response After Intake of Vitalose
|
N/A | |
| Completed |
NCT04272450 -
Respiratory Muscle Strength in Different Age Groups
|
||
| Completed |
NCT02044679 -
Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions
|
N/A | |
| Completed |
NCT01402973 -
Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products
|
N/A |