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Unknown

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study

Phase 1
Waitlist Available
Led By Hugh Coleman, MD
Research Sponsored by PegBio Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from group a1 until group b4. the study duration for each subject in part a will be approximately 8 weeks. the study duration for each subject in part b will be approximately 11 weeks.

Summary

This trial tests a new drug called PB-718 to see if it is safe and how it behaves in the body. Healthy volunteers will receive injections under the skin. Researchers will monitor how the drug is absorbed, processed, and eliminated from the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from group a1 until group b4. the study duration for each subject in part a will be approximately 8 weeks. the study duration for each subject in part b will be approximately 11 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from group a1 until group b4. the study duration for each subject in part a will be approximately 8 weeks. the study duration for each subject in part b will be approximately 11 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Pharmacokinetic (PK) profile

Trial Design

10Treatment groups
Experimental Treatment
Group I: Group B4Experimental Treatment2 Interventions
PB-718 vs placebo
Group II: Group B3Experimental Treatment2 Interventions
PB-718 vs placebo
Group III: Group B2Experimental Treatment2 Interventions
PB-718 vs placebo
Group IV: Group B1Experimental Treatment2 Interventions
PB-718 vs placebo
Group V: Group A6Experimental Treatment2 Interventions
PB-718 vs placebo
Group VI: Group A5Experimental Treatment2 Interventions
PB-718 vs placebo
Group VII: Group A4Experimental Treatment2 Interventions
PB-718 vs placebo
Group VIII: Group A3Experimental Treatment2 Interventions
PB-718 vs placebo
Group IX: Group A2Experimental Treatment2 Interventions
PB-718 vs placebo
Group X: Group A1Experimental Treatment2 Interventions
PB-718 vs placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PB 718
2020
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PegBio Co., Ltd.Lead Sponsor
14 Previous Clinical Trials
2,866 Total Patients Enrolled
CovanceIndustry Sponsor
120 Previous Clinical Trials
12,885 Total Patients Enrolled
Hugh Coleman, MDPrincipal InvestigatorDaytona Beach CRU
3 Previous Clinical Trials
1,750 Total Patients Enrolled
~15 spots leftby Dec 2025
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